APS Standard Operating Procedure

VQD-SOP-072500 v 7.0

Progress Data Change

and SKUand SKU Change
Change in GSK GLAMS
in GSK GLAMS

Revision History

Version Reason For Revision

1.0 For UAT only
2.0 First issue of the Document for Production use, updated post UAT
Document revised to:
 update layout of each Task action as per Working Instruction Template.
 add GRA and GSC Medical Device in the Roles Involved section and in the applicable
steps.
 add instructions for CMO Proxy.
3.0  remove references to “Clone” option.
 remove “CMO/Site/Proxy” from “Initate SKU” and “Define and Update impacted SKU”
steps of SKU Change.
 update title of Appendix 1 and 2 by removing “How to populate”.
 update Appendix 2 to add “Product Characteristics” as field editable via Pack Change for
existing SKU.
4.0  Document revised to add Instructions for 3PC Proxy.
 In Scope section updated to clarify that External Manufacturing will follow internal GSK
GLAMS Proxy guidance when acting as CMO proxy.
5.0 For UAT only.
 “Introduction” section rephrased to remove reference to product supplied by Contract
Manufacturing Organisation (CMO) in scope for Pharma External Manufacturing (EM).
 “Purpose” section updated with example of components impacted (PPC, NPC, DWG,
SPEC…)
 “In scope” section reworded, Supplier/BoM update for any type of component (SKU
excluded) added to the Data Change section.
 “Out of scope” section updated with reference to relevant SOP for Drawing,
Specification, Site/Supplier, NPC and Asset management and reworded in alignment
with “In scope” section.
 “Roles involved” updated with Data Change Coordinator, Pach Technologist, Vx
Global Function, Packaging Data Quality, CAD Operator and Dispatcher.
 “Process flow charts” updated and Packaging Templates added.
 Data Change:
o “Initate Data Change” step 1.1.1 updated to clarify that for Packaging driven Data
Change the Initiator may be Pack Technologist, Vx Global Function or Packaging Data
Quality.
o “Define and Update Impacted items”:
 step 1.2.1 updated to clarify that for Packaging driven Data Change: the task may
be performed by Pack Technologist or Vx Global Function and with instruction to
add ‘Packaging driven’ as Reason for Change.
 step 1.2.4 added reference to ‘Linked Drawing’, ‘Linked NPC’ and ‘Linked Spec’.
 step 1.2.8 removed Overprint Form example.
 step 1.2.9 and 1.2.10 Artwork Coordinator replaced with Data Change Coordinator.
o “Data Change Routing” updated with:
 step 1.3.1 updated with details on roles acting as that Data Change Coordinator.

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  new step 1.3.4 added with details on different Templates, following steps
renumbered.
 step 1.3.6 added instruction to remove unrequired task and to ensure at least one
Approver is assigned.
 step 1.3.8 removed Overprint Form example.
o “Review Data Change”
 step 1.4.5 removed Overprint Form example.
 step 1.4.6 Artwork Coordinator replaced with Data Change Coordinator
o “Data Change Pre-Library”
 Task renamed from example “Data Change Move to Library” to “Data Change Pre-
Library”
 Artwork Coordinator replaced with Data Change Coordinator.
 Details on ‘Move to Library and Notify Dispatch’ and on notification sent for Dispatch
in case of Supplier Change added.
o New Tasks from 1.7 to 1.14 added for Packaging Data Change.
 SKU Change:
o “Initate SKU Change” step 2.1.1 updated to clarify that for Packaging driven SKU
Change Site is the Initiator.
o “Define and Update Impacted SKU”
 step 2.2.1 updated to clarify that for Packaging driven SKU Change: the task is
performed by Site and with instruction to add ‘Packaging driven’ as Reason for
Change.
 step 2.2.8 removed Overprint Form example. Updated to specify that Overprint
Form is uploaded in SKU ‘Documents’ Tab.
 step 2.2.11 added details on Intermediates and reference for GSK Site to follow
VQD-SOP-079338 - How to Create and Maintain a BOM in GSK GLAMS.
o “SKU Change Routing”
 new step 2.3.3 added with details on different Templates, following steps
renumbered.
 2.3.9 updated to specify that Overprint Form is uploaded in SKU ‘Documents’ Tab.
o “Review SKU Change” step 2.4.5 updated to specify that Overprint Form is uploaded in
SKU ‘Documents’ Tab.
o “Provide SKU and BOM details”
 step 2.5.6 updated to specify that Overprint Form is in SKU ‘Documents’ Tab.
 step 2.5.9 reference added for GSK Sites to follow VQD-SOP-079338 - How to
Create and Maintain a BOM in GSK GLAMS
o New Tasks from 2.8 to 2.11 added for Packaging SKU Change.
 Appendix 1 - Data Change and SKU Change fields Data Change Coordinator added.
 Appendix 2 - SKU and components fields updated with new Packaging fields, section
for NPC, DWG, SPECs added and “GSK GLAMS step” column removed.
 Appendix 3 - GSK GLAMS System instruction updated with new System Instruction
and some Titles reworded.
 Appendix 4 - How to Cancel a Change updated to clarify that any new item and/or any
item revision that is not required must be cancelled manually by person cancelling the
change or by AWC via Tracker.
6.0 Version 5.0 never effective as in scope for UAT only.
Version 6.0 for Production use contains all updates mentioned in the Revision History for
version 5.0 above and the additional amendments post UAT as below:
 Reference to relevant GSK GLAMS System instruction added in each step.
 Out of scope section updated with reference to VQD-SOP-079525 - How to progress a

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 Non-Printed Component Change in GSK GLAMS.
 Data Change:
o “Initate Data Change” step 1.1.4 and “Define and Update Impacted items” step 1.2.3
instruction added to include ‘Packaging Driven’ as 'Reason for Change' for Packaing Data
Change.
o “Data Change Routing” step 1.3.8 and “Review Data Change” step 1.4.5: reference to
Overprint Form/Braille replaced with generic reference to supporting document.
o “Site Review Data Change” step 1.8.6 replace sentence “send a Comment to Data Change
Coordinator and Site” with “send a Comments to all required parties”.
 SKU Change:
o “Define and Update impacted SKU” step 2.2.6 updated to clarify that for Packaging Driven
SKU Change where a new SKU is created, Site is responsible to insert the SKU "Site Item
Code", "Packaging Platform" and "Description"; step 2.2.9 references to Artwork Release
Date, Regulatory Submission Date and Regulatory Required Date replaced with
Implementation Date.
 Appendix 2 - SKU and components fields:
o CRSF Requirement field added as editable via Pack Change for existing SKU.
o Site added as Owner of SKU and PPC Lifecycle Phase field.
 Appendix 4 - How to Cancel a Change: reference to Data Change Coordinator added.
7.0 Document revised to:
 include Repacking in the scope, reference Repacker Proxy role and relevant activities
where applicable.
 add instructions for Artwork Coordinator/FASP on how to manage Approving Market in
Changes affecting Packs owned by a Third-Party Customer (3PC) in steps: 1.3.6 “Data
Change Routing” and 2.3.7 “SKU Change Routing”.
 Data Change step 1.1.1 updated to clarify that External Manufacturing (EM) team act as
Initiator for discontinuation of SKUs, unless differently agreed between External
Manufacturing and CMO.
 Note added in “Appendix 1 – Data and SKU Change Field” and “Appendix 2 – SKU and
component fields” to clarify that the entry “Site” in the Owner column may refer to CMO,
GSK Site, Repacker.
 Reason for Change field in “Appendix 1 – Data and SKU Change fields” updated to
clarify that update to Shelf-life are in scope only if overprint are impacted.
 Appendix 4 – How to Cancel a Change updated to specify that when a change is
cancelled, any new item and/or any item revision linked to the Change is automatically
cancelled.

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Contents
Revision History............................................................................................................................................. 1
Terms and Definitions.................................................................................................................................... 6
Introduction..................................................................................................................................................... 6
Purpose........................................................................................................................................................... 6
In scope........................................................................................................................................................... 6
Out of scope.................................................................................................................................................... 8
Roles involved................................................................................................................................................ 9
Process flow Chart(s)..................................................................................................................................... 9
Process.......................................................................................................................................................... 11
1. Data Change........................................................................................................................................... 11
1.1 Initiate Data Change....................................................................................................................... 11
1.2 Define and Update Impacted Items................................................................................................. 12
1.3 Data Change Routing..................................................................................................................... 14
Standard Data Change................................................................................................................................. 16
1.4 Review Data Change...................................................................................................................... 16
1.5 Approve Data Change.................................................................................................................... 17
1.6 Data Change Pre-Library................................................................................................................ 18
Packaging Data Change............................................................................................................................... 19
1.7 Pack Tech Review Data Change.................................................................................................... 19
1.8 Site Review Data Change............................................................................................................... 20
1.9 Pack Tech Approve Data Change................................................................................................... 21
1.10 Site Approve Data Change............................................................................................................. 21
1.11 Approve Data Change.................................................................................................................... 22
1.12 Vx Global Approve Data Change.................................................................................................... 22
1.13 Data Change Pre-Library................................................................................................................ 23
1.14 File Dispatch................................................................................................................................... 23
2. SKU Change........................................................................................................................................... 24
2.1 Initiate SKU Change....................................................................................................................... 24

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 2.2 Define and update impacted SKU................................................................................................... 25
2.3 SKU Change Routing...................................................................................................................... 26
Standard SKU Change................................................................................................................................. 28
2.4 Review SKU Change...................................................................................................................... 28
2.5 Provide SKU and BOM Details....................................................................................................... 29
2.6 Approve SKU Change..................................................................................................................... 31
2.7 SKU Change Pre-Library................................................................................................................ 31
Packaging SKU Change............................................................................................................................... 32
2.8 Review SKU Change...................................................................................................................... 32
2.9 Site Approve SKU Change.............................................................................................................. 33
2.10 Vx Global SKU Change Approval................................................................................................... 33
2.11 SKU Change Pre-Library................................................................................................................ 34
Training Requirement(s).............................................................................................................................. 34
Reference(s).................................................................................................................................................. 35
Appendices................................................................................................................................................... 36
Appendix 1 – Data and SKU Change fields................................................................................................ 36
Appendix 2 – SKU and component fields.................................................................................................... 37
Appendix 3 – GSK GLAMS System instructions......................................................................................... 45
Appendix 4 – How to Cancel a Change...................................................................................................... 45

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Terms and Definitions

All terms and definitions are available at VQD-REF-004217 - APS system and process glossary

If throughout the process you are unsure about how to proceed, raise a ticket to APS Support to get help.

Introduction

The 2 scenarios below (i.e.: Data Change and SKU Change) apply where a Rx/Vx product is managed via
GSK GLAMS system.

Purpose

This procedure details the steps for progressing Data and SKU Change, where one or more components
(e.g.: PPC, NPC, DWG, SPEC…) and/or SKUs are affected.

A key requirement is that the information that is changing does not have any impact on the Artwork content.

In scope

1. Data Change:

o Meta data change (items attribute) where the associated file (e.g.: Artwork, Drawing) is not impacted
by the change. Refer to Appendix 2 - SKU and component fields for the list of fields and how to
use them. This scenario includes and is not limited to:
 Lifecycle phase change (except for products that are being Divested).
 Supplier updates
 Market extension for a new market with NO Pack change. The new market (either Approving OR
Additional) can accept the existing artwork. Note: in this case, the Market raises the Data
Change, upon My PSR approval, to add themselves.

o BoM updates for any type of component, as applicable, GSK Site to follow VQD-SOP-079338 - How
to Create and Maintain a BOM in GSK GLAMS. This excludes BoM updates to SKU, which are
managed via SKU Change.

Note:

 When applicable, progression of changes where a Proxy acts on CMO behalf. It is Proxy
responsibility to complete all the CMO steps and related activities, liaising with CMO to obtain or
provide information required for change progression. Where applicable, External Manufacturing will
follow internal GSK GLAMS Proxy guidance when acting as CMO proxy

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  When applicable, progression of changes where a Proxy acts on behalf of a Third-Party Customer
(3PC), i.e.: Non-GSK Market Authorisation Holder without direct access to GSK GLAMS. It is 3PC
Proxy responsibility to complete all the 3PC steps and related activities, liaising with 3PC to obtain or
provide information required for change progression.

 When applicable, progression of changes on Repacking items (using the “Standard Data Change
Template”) where a Proxy acts on Repacker’s behalf. It is Repacker Proxy responsibility to complete
all the Repacker steps and related activities, liaising with Repacker to obtain or provide information
required for change progression.

2. SKU Change:

o Creation of a new Finished Pack/SKU or Intermediate not requiring the file creating/amending of an
artwork (e.g.: new Market taking an existing printed component with relevant artwork).

o BoM updates for SKU,GSK Site to follow VQD-SOP-079338 - How to Create and Maintain a BOM
in GSK GLAMS.

o Overprint change.

Note:

 When applicable, progression of changes where a Proxy acts on CMO behalf. It is CMO Proxy
responsibility to complete all the CMO steps and related activities, liaising with CMO to obtain or
provide information required for change progression.Where applicable, External Manufacturing will
follow internal GSK GLAMS Proxy guidance when acting as CMO proxy

 When applicable, progression of changes where a Proxy acts on behalf of a Third-Party Customer
(3PC), i.e.: Non-GSK Market Authorisation Holder without direct access to GSK GLAMS. It is 3PC
Proxy responsibility to complete all the 3PC steps and related activities, liaising with 3PC to obtain or
provide information required for change progression.

 When applicable, progression of changes on Repacking SKU (using “Standard SKU Change
Template”) where a Proxy acts on Repacker’s behalf. It is Repacker Proxy responsibility to complete
all the Repacker steps and related activities, liaising with Repacker to obtain or provide information
required for change progression.

For additional guidance refer to:

VQD-WI-051469 - Additional guidance on artwork change scenarios in GSK GLAMS

VQD-WI-051468 - How to manage Intermediates between a CMO in GSK GLAMS and a GSK Site in
Harmony
VQD-WI-051491 - Understanding item status and lifecycle phases in GSK GLAMS

For guidance on GSK GLAMS System Instructions refer to Appendix 3 - GSK GLAMS System
Instructions. General navigation guidelines are included in VQD-WI-051388 - GSK GLAMS Basic

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Navigation System Instruction and VQD-WI-051395 - GSK GLAMS Tracker and Library System
Instruction.

Escalation Route: All deviations from Global Standard Operating Procedures must be escalated to Artwork
and Packaging Services (APS) Process Team before progressing. Please submit a ServiceNow ticket to get
help.

Out of scope

Both for Data Change and SKU Change:

• Lifecycle phase change due to a Divestment. Refer to VQD-SOP-015866 - Divestment Process

• Changes impacting Artwork, refer to VQD-SOP-072496 - Progress an artwork change in GSK GLAMS

• Changes impacting Drawing, refer to VQD-SOP-079337 - How to Progress a Drawing Change in GSK
GLAMS

• Changes impacting Specification, refer to VQD-SOP-079336 - How to Progress a Specification

Change in GSK GLAMS

• New Site/Supplier creation or updates to existing Site/Supplier follow VQD-SOP-072498 - Managing

Vendors in GSK GLAMS

• Changes to create new Non Printed Component (NPC), refer to VQD-SOP-079525 - How to progress a
Non-Printed Component Change in GSK GLAMS

• Creation or revision of non-production files (darfts, skeletons or mock-ups). Refer to VQD-SOP-072497 -

Progress a non production artwork change in GSK GLAMS

• Upload of Assets, refer to VQD-SOP-079715 - Progress Studio Assets in GSK GLAMS

For Data Change (as this is in scope for SKU Change):

o Creation of a new Finished Pack or Intermediate not requiring the file creating/amending of an artwork
(e.g. new Market taking an existing printed component with relevant artwork).

o BoM updates for SKU.

o Overpint change.

For SKU Change (as this in scope for Data Change):

o Meta data change (Item attribute) where the associated file (e.g.: Artwork, Drawing) is not impacted by
the change. This scenario includes and is not limited to:

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  Lifecycle phase change (except for products that are being Divested).
 Supplier updates
 Market extension for a new market with NO Pack change. The new market (either Approving OR
Additional) can accept the existing artwork. Note: in this case, the Market raises the Data Change,
upon My PSR approval, to add themselves

o BoM updates for any type of component (SKU excluded), as applicable.

Roles involved

LOC, GRA, Artwork Coordinator/FASP, CMO/Site/CMO Proxy/Repacker Proxy, GSC Medical Device, 3PC
Proxy, Data Change Coordinator, Dispatcher, Pack Technologist, Vx Global Function, Packaging Data
Quality, CAD Operator,

Process flow Chart(s)

1.Data Change

1.a Standard Data Change

LOC may be GSK LOC or a 3PC Proxy acting on a 3PC behalf.

Use this template for Repacking Data Change.

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 1.b Packaging Data Change
Process variant for packaging driven data changes where pack tech/site and market approval are required.

LOC may be GSK LOC or a 3PC Proxy acting on a 3PC behalf.

Site may be a CMO, a CMO Proxy, a or a GSK Site.

2.SKU Change

2.a Standard SKU Change

LOC may be GSK LOC or a 3PC Proxy acting on a 3PC behalf.

Site may be a CMO, a CMO Proxy, a Repacker Proxy or a GSK Site.
Use this template for Repacking SKU Change.

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 2.b Packaging SKU Change
Process variant for packaging driven BOM SKU updates.

LOC may be GSK LOC or a 3PC Proxy acting on a 3PC behalf.

Site may be a CMO, a CMO Proxy or a GSK Site.

Process

1. Data Change

1.1 Initiate Data Change

(Roles: LOC, Artwork Coordinator/FASP, CMO/Site/Proxy, 3PC Proxy, Pack Technologist, Vx Global
Function, Repacker Proxy)
Refer to VQD-WI-051389 - Initiating Changes in GSK GLAMS System Instruction
Step Action Additional information
1.1.1  For updates on meta data owned by Refer to Appendix 2 – SKU and component fields for
Market that might have impact on Site, the completed list of field.
Site confirmation is required before
If CMO Proxy is involved they get relevant information
raising the Data Change.
from the CMO.
 Artwork Coordinator is the Initiator of
Data Change to manage Additional If 3PC Proxy is involved they:
Markets from a Pack.  get relevant information from the 3PC, as a
 Market is the Initiator of Data Change for minimum:
any other updates. o site item code of impacted SKU/PPC
 For Packaging driven Data Change, the o description of the Change

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 Initiator may be Pack Technologist or Vx o 3PC contact and email address
Global Function. o implementation date
 External Manufacturing (EM) team act as  enter all available information on the VQD-FRM-
Initiator for discontinuation of SKUs 097312 GSK GLAMS Third Party Customer
supplied by CMOs managed by EM (3PC) Request Form and provide it to 3PC.
organisation, unless differently agreed
If Repacker Proxy is involved they get relevant
between External Manufacturing and information from the Repacker.
CMO.
1.1.2 Create the change, selecting the relevant
‘New Request’ category. For a change to
update meta data, select ‘Data Change
Request’.
1.1.3 Complete the associated fields on the Refer to Appendix 1 – Data and SKU change fields
‘Initiate Data Change’ window. for the list of fields and how to use them. Fields with
asterisk (*) are required at this stage. Others can be
populated also at next stage.

For progressing a Data change which doesn’t require

Market involvement (e.g.:Pack Tech updating the
attributes for a drawing) update the “Approving
Market” attribute as “N/A”.
1.1.4 The ‘Reason for Change’ and the details of For Packaging Data Change add ‘Packaging Driven’ as
the meta data change required must be 'Reason for Change'.
clearly stated.
1.1.5 Click on ‘Submit’ to create the change. Change ID is shown in Part Number field, on top. Take
note of the Change ID, as it is needed in the next step.
1.1.6 ‘Close’ the window to proceed further.

1.2 Define and Update Impacted Items

(Roles: LOC, Artwork Coordinator/FASP, CMO/Site/Proxy, 3PC Proxy, Pack Technologist, Vx Global
Function, Repacker Proxy)
Refer to VQD-WI-051389 - Initiating Changes in GSK GLAMS System Instruction
Step Action Additional information
1.2.1 Select the task. Check the Rejection Reason Tab of the Change to
understand if a Rework or Rejection has been selected.

Note: for Packaging driven Data Change

 this step may be performed by Pack Technologist,
Vx Global Function or Packaging Data Quality.
 Insert ‘Packaging driven’ as ‘Reason for Change’
as this will ensure involvement of the relevant Data
Change Coordinator.
1.2.2 Access the change and in ‘Define and Refer to Appendix 1 – Data and SKU change fields
Update Impacted Items’ tab, review the for the list of fields and how to use them.
fields previously populated, filling in the
missing ones. If CMO Proxy is involved they:
 fill in the fields as per information received from the
CMO

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  provide to CMO a screenshot of the updated field.

If 3PC Proxy is involved they:

 fill in the fields as per information received from the
3PC.
 provide to 3PC a screenshot of the updated field.

If Repacker Proxy is involved they include relevant

details as per information received from the Repacker.
1.2.3 Ensure the correct value(s) in ‘Reason for For Packaging Data Change add ‘Packaging Driven’ as
Change’ field is added. 'Reason for Change'.
1.2.4 Identify and add affected items (components Within the relevant section click on ‘Link’ and run the
and SKUs) to the change. relevant search to identify the affected components.
Components are added in ‘Linked Artwork’ Once the affected component is identified click on ‘Link’
section (or in the ‘Linked Drawing’, ‘Linked button.
Non-Printed Component, ‘Linked Material
Specification’, ‘Linked General
Specification’ section, as applicable) SKUs
in ‘Linked SKU’ of the Change.
1.2.5 Ensure there is consistency between the
Approving and Additional Markets fields at
components and Change level.
1.2.6 Ensure that the full impact assessment is The site’s manufacturing system or regulatory system is
performed, and the required items are added the master source of data and the GSK GLAMS system
to the change. should be updated to reflect this. Make sure that the
impact on other packs and items is fully understood
before completing the relevant updates.
1.2.7 Check any pending changes which can be
combined. If not possible, possibly avoid
progressing new changes until the previous
change is released.
1.2.8 In the ‘Documents’ tab of the Change, add If 3PC Proxy is involved, they attach the filled GLAMS
any supporting document that relates to the 3PC Request Form.
Change and not the single components.
Select the correct Category that applies.
1.2.9 Create a Comment and involve required
parties to discuss any pending point.
Comment related to Implementation dates
must involve Data Change Coordinator and
CMO/Site.
1.2.10 Ensure the correct Data Change Coordinator
is assigned to the ‘Data Change
Coordinator’ field in the Change.
1.2.11 Access each SKU/component via the Refer to Appendix 2 - SKU and component fields for
relevant ‘Edit’ button functionality and edit the list of fields and how to use them.
the required fields.
For the Printed and the Non-Printed Components the
BOM linking/unlinking to the respective
drawing/Material and General Specification items can

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 be done in the respective Edit page of the printed and
the non-printed component

Pre-Assembled Component BOM linking can be

performed. Linking the PPC/NPC/DWG/Spec to the
Pre-Assembled NPC component.
1.2.12 Go back to ‘Define and Update Impacted Click on ‘Cancel’ to cancel the Change, if it is not
Items’ task and click on Submit to proceed required anymore
further.
1.2.13 Click on ‘Cancel’ to cancel the Change.

1.3 Data Change Routing

(Role: Data Change Coordinator)
Refer to VQD-WI-051390 - Performing Routing task in GSK GLAMS System Instruction
Step Action Additional information
1.3.1 For group tasks, assign the task and Understand the type of Data Change, considering that:
change the Job Owner to yourself.  the Data Change Coordinator for Packaging driven
Data Changes is Pack Technologist, Vx Global
Function or Packaging Data Quality.
 for other scenarios the Data Change Coordinator is
Artwork Coordinator/FASP.

Check the Rejection Reason Tab of the Change to

understand if a Rework or Reject has been selected.
1.3.2 Access Change Routing panel and Information about the change can also be accessed via
navigate to the Change to review the ‘Job Info’ option on the right.
change information and component
information entered by the initiator. If any
information is incorrect/not complete,
liaise with the initiator of the change to
complete. Rework can be triggered at this
stage, if required.
1.3.3 Check change/component information
versus information on title block of SKUs
and components, to ensure there is at
least task for each:
• Approving Market (if they appear on title
block in ‘Approving Markets’ field)
• Central Approving function (if they
appear on title block as ‘Central Approving
Function’)
• Site (as they appear in Artwork Details
Tab, Artwork – General Information
section field of components) – manual
task creation is required.
• Additional Market (if they appear in title
block as ‘Additional Markets’ and/or
‘Additional Market Pending Acceptance’) – Note: Additional Market Approval Task isn’t created as
manual task creation is required. the “Additional Market Review Change” of Pack Change -

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 • All Market driven Data Changes MUST no Accept/Decline option available.
have the Approving Market(s) as
an Approver
• If the product is dual sourced (supplied by
different sites) then each site must be
included in the plan.
1.3.4 Select relevant Template depending on If Standard Data Change
the scenario (‘Data_Change_Standard_Template’) is selected:
completion of ‘Data Change Routing’ triggers the
Approving Markets/Central Functions Review tasks
followed by Approving Markets/Central Functions
Approval tasks. Refer to steps from 1.4 to 1.6.

If Packaging Data Change

(‘Data_Change_Pack_Tech_Site_Markets_Template’)
is selected:
completion of ‘Data Change Routing’ triggers the Pack
Tech/Site Review tasks, followed by Pack
Teck/Site/Approving Market and Vx Global Function
Approval task.
Additionally, a File Dispatch Task goes in process upon
‘Data Change Pre-Library’ completion. Refer to steps from
1.7 to 1.14.
1.3.5 Assigns Users who will be involved in the If CMO Proxy is involved, Data Change Coordinator to
change and check the relevant resource inform Proxy in case LOC updates any field relevant for
group. CMO and/or Overprint Form is present (and need to be
shared with CMO).

If Repacker Proxy is involved, Data Change Coordinator

to inform Proxy in case LOC updates any field relevant for
Repacker (and need to be shared with Repacker).
1.3.6 Remove unrequired tasks and/or add Ensure at least one Approver is assigned.
additional boxes if more tasks are required
(e.g.: if Additional Market approval is If the pack is supplied to one Approving Market only, and
needed), ensuring relationship are built they initiated the change, agree with them whether a
further task for Review Data Change Task is needed; if
accordingly, in the plan. not, cancel it.

If Additional Market/s are involved, manually add a

Review Data Change and a Approve Data Change Task
for each Additional Market.

For Third Party Customer (3PC) keep only the 3PC

“Review Data Change” and “Approve Data Change” Tasks
and delete the specific Country “Review Data Change”
and “Approve Data Change” Tasks (e.g.: keep 3PC
Biogaran Tasks and delete France Tasks).

The Packaging Data Change template by default has a

LOC ‘Approve Data Change’ Task. Remove this task if
the task is not applicable for the progression of the data
change, For example , Pack Tech initiating a data change
for a drawing item will not require a Market approval task.

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1.3.7 Adjust task lead-time accordingly. Review the timeline in the plan to ensure milestones are
Standard lead-times are entered by the aligned to the deadlines for the change (or best estimate
system, but they can be updated of deadlines if they are not available at this point).
depending on the scenario/specific
business needs.
1.3.8 Review supporting documents in If a new supporting document is to be added due to
‘Documents’ tab. rework, ensure it is clearly identified including version and
that the site have been made aware this version
supersedes the version.
1.3.9 Consider any Comment raised during
previous stages and if they are resolved.
Facilitate and reflect any agreements
regarding the dates between the relevant
parties, ensure the change is aligned to
the agreed dates and the same are
reflected in the associated date fields.
Comments related to Implementation date
must involve LOC (s) and CMO/Site.
1.3.10 Create a Comment, if needed, and involve
required parties to discuss any pending
point.
1.3.11 ‘Submit’ the task to proceed further or
‘Rework’ to move back the Change to
Define and update affected items Task.

Standard Data Change

1.4 Review Data Change

(Role: LOC, GRA, GSC Medical Device, 3PC Proxy)
This step applies when Approving Markets are associated to SKU and components and it is always
required if there are multiple approving Market.
Refer to VQD-WI-051391 - Performing Review tasks in GSK GLAMS System Instruction
Step Action Additional information
1.4.1 For group tasks, assign the task to Check the Rejection Reason Tab of the Change to
yourself. understand if a Rework or Reject has been selected.

If 3PC Proxy is involved and the Data Change is not

initiated by 3PC Proxy and/or if there are other Approving
Markets/Central Function involved, 3PC Proxy to:
 provide to 3PC details on the update done via Data
Change.
 provide to 3PC a screenshot of the updated field.
1.4.2 Access the change and in ‘Review Refer to Appendix 1 – Data and SKU change fields for
Change’ tab, review the fields previously the list of fields and how to use them.
populated (fields and documents attached)
filling in the missing ones. Ensure that any

16
 information relevant to your role is correct.
1.4.3 Ensure the correct value(s) in ‘Reason for
Change’ field is added.
1.4.4 Review of information only is required if Full provision of information is required if Approving
Approving Market is the one initiating the Market was not the initiator (e.g., multimarket pack) - for
change. instructions refer to ‘Define and Update Impacted Items’
step.
1.4.5 Review and/or upload supporting If a new supporting document is to be added due to
documents in ‘Documents’ tab. rework, ensure it is clearly identified including version and
that the site have been made aware this version
supersedes the version.
1.4.6 If any information is missing, send a
Comment to Data Change Coordinator
and Market stating which information is
missing. Create a Comment, if needed,
and involve required parties to discuss any
pending point. Comments related to
Implementation dates must involve LOC(s)
and Data Change Coordinator.
1.4.7 Review the SKUs and/or components Perform this action for each affected component.
added to the change. Review and/or
update fields as required.
1.4.8 Go back to ‘Review Data Change’ task
and complete to proceed further. Click on
‘Rework’ if any amendment is needed.

1.5 Approve Data Change

(Roles: LOC, GRA, GSC Medical Device, 3PC Proxy)
Refer to VQD-WI-055944 - Performing Approval tasks in GSK GLAMS System Instruction
Step Action Additional information
1.5.1 For group tasks, assign the task to Check the Rejection Reason Tab of the Change to
yourself. understand if a Rework or Reject has been selected.

If 3PC Proxy is involved, they provide to 3PC a screenshot

of the updated field.
1.5.2 The purpose of this step for Market
approver is to review and
approve changes done during previous
step (i.e.: ‘Define and Update affected
items’ and ‘Review Data Change’) and
to confirm they are acceptable from a
regulatory point of view.
1.5.3 Ensure all requested changes have been
executed correctly and are consistent
across the same pack, when applicable.
1.5.4 Ensure that the content of forms (e.g. the
overprint form) is reviewed as well as the

17
 information in the system.
1.5.5 All Approving Markets/Central Approving
Functions must be approvers of their
associated components.
If other approvers must be assigned, click
on ‘Rework’ and then liaise with the Data
Change Coordinator to add them.
1.5.6 Should there be any delays to the original
agreed deadlines, raise a Comment
involving CMO/Site and Data Change
Coordinator to agree new Implementation
dates.
1.5.7 Approve or reject the task and apply e- To sign off insert e-signature.
signature. Approval is a confirmation that
the information in the GSK GLAMS If 3PC Proxy is involved, they approve to record that the
system is correct. Change meets 3PC requirements.
‘Approve’ the task to progress further or
‘Reject’ and select the Reject option.

1.6 Data Change Pre-Library

(Role: Data Change Coordinator)
Refer to VQD-WI-051391 - Performing Review tasks in GSK GLAMS System Instruction
Step Action Additional information
1.6.1 When Data Change is Approved, the If CMO Proxy is involved, Data Change Coordinator
updated component is moved to the Coordinator to inform CMO Proxy of Change completion.
library but to complete the overall
Change completion of Data Change If 3PC Proxy is involved, Data Change Coordinator to
inform 3PC Proxy of Change completion.
Pre-Library is needed:
If Repacker Proxy is involved, Data Change Coordinator to
 click on ‘Move to Library’ to inform Repacker Proxy of Change completion.
release the change to the Data
Change Library.

 in case Dispatch is required, click on

‘Move to Library and Notify
Dispatch’ to trigger the notification
to Dispatcher.
Upon completion of ‘Move to Library and Notify Dispatch’
Task a notification is sent to Dispatcher to perform
Dispatch. Dispatcher follows VQD-WI-055982 - Managing
dispatch of files in GSK GLAMS.

Packaging Data Change

18
Note: the first 3 Tasks (Initate Data Change, Define and Updated Impacted items, Data Change Routing) and
associated instructions are the same of the Standard Data Change.

1.7 Pack Tech Review Data Change

(Role: Pack Tech)
Refer to VQD-WI-051391 - Performing Review tasks in GSK GLAMS System Instruction
Step Action Additional information
1.7.1 For group tasks, assign the task to yourself. Check the Rejection Reason Tab of the Change to
For tasks under “My Active Tasks” click on understand if a Rework or Reject has been selected.
the Part Number to review the Data change
order and the items.

1.7.2 Access the change and in ‘Review Data Refer to Appendix 1 – Data and SKU change fields
Change’ tab, review the fields previously for the list of fields and how to use them.
populated (fields and documents attached)
filling in the missing ones. Ensure that any
information relevant to your role is correct.

1.7.3 Ensure the correct value(s) in ‘Reason for

Change’ field is added.

1.7.4 Review and/or upload supporting

documents in ‘Documents’ tab.

1.7.5 Review the affected items added the Perform this action for each affected component.
change i.e. SKU/PPC/NPC/General
Spec/Material Spec/Drawing items added to
the change.

Review and/or update data values to the

attributes as required.

Review and Update BOM links if applicable.

i.e. building an assembled component or
linking approved DWG/Spec to the
NPC/PPC.
1.7.6 If any information is missing, and if any Before clicking on ‘Rework’ , Send a Comment to Data
amendment is needed. Change Coordinator and Site stating which information
Click on ‘Rework’ in the ‘Review Data is missing. Create a Comment, if needed, and involve
Change’ tab required parties to discuss any pending point.
Reject Reason is mandatory for Rework. On Rework the workflow moves to “Data change
Routing” task where the Data Change Coordinator can
move it back to “Define and update Impacted items”
task where the initiator can provide
clarification/amendments as required and progress the
entire workflow again.
1.7.7 Go back to ‘Review Data Change’ task
and Complete to proceed further. The

19
 workflow advances to next task.

1.8 Site Review Data Change

(Role: Site)
Refer to VQD-WI-051391 - Performing Review tasks in GSK GLAMS System Instruction
Step Action Additional information
1.8.1 For group tasks, assign the task to yourself. Check the Rejection Reason Tab of the Change to
understand if a Rework or Reject has been selected.
For tasks under “My Active Tasks” click on
the Part Number to review the Data change
order and the items.

1.8.2 Access the change and in ‘Review Data Refer to Appendix 1 – Data and SKU change fields
Change’ tab, review the fields previously for the list of fields and how to use them.
populated (fields and documents attached)
filling in the missing ones. Ensure that any
information relevant to your role is correct,
including the Implementation Date.

1.8.3 Ensure the correct value(s) in ‘Reason for

Change’ field is added.

1.8.4 Review and/or upload supporting

documents in ‘Documents’ tab.

1.8.5 Review the affected items added the Perform this action for each affected component.
change i.e. SKU/PPC/NPC/General
Spec/Material Spec/Drawing items added to
the change.
Review and/or update data values to the
attributes as required.

Review and Update BOM links if applicable.

i.e. building an assembled component or
linking approved DWG/Spec to the
NPC/PPC.
1.8.6 If any information is missing, and if any Before clicking on ‘Rework’ , send a Comment to all
amendment is needed. required parties stating which information is missing.
Click on ‘Rework’ in the ‘Review Data Create a Comment, if needed, and involve required
Change’ tab. parties to discuss any pending point.
Reject Reason is mandatory for Rework. On Rework the workflow moves to “Data change
Routing” task where the Data Change Coordinator can
move it back to “Define and update Impacted items”
task where the initiator can provide
clarification/amendments as required and progress the
entire workflow again.

1.8.7 Go back to ‘Review Data Change’ task

20
 and Complete to proceed further. The
workflow advances to next task.

1.9 Pack Tech Approve Data Change

(Role: Pack Tech)
Refer to VQD-WI-055944 - Performing Approval tasks in GSK GLAMS System Instruction
Step Action Additional information
1.9.1 For group tasks, assign the task to yourself. Check the Rejection Reason Tab of the Change to
understand if a Rework or Reject has been selected.
For tasks under “My Active Tasks” click on
the Part Number to approve the Data
change order and the items.

1.9.2 The purpose of this step for the Pack Tech

approver to review and approve changes
done during previous step (i.e.: ‘Define and
Update affected items’ and ‘Review Data
Change’) and to confirm the acceptance.

1.9.3 Approve or reject the task and apply e- On Rejection the workflow moves to “Data change
signature. Approval is a confirmation that Routing” task where the Data Change Coordinator can
the information in the GSK GLAMS system move it back to “Define and update Impacted items”
is correct. task where the initiator can provide
clarification/amendments as required and progress the
‘Approve’ the task to progress further or entire workflow again.
‘Reject’ and select the Reject option under
the “Site Approve Data Change’ tab.

1.10 Site Approve Data Change

(Role: Site)
Refer to VQD-WI-055944 - Performing Approval tasks in GSK GLAMS System Instruction
Step Action Additional information
1.10.1 For group tasks, assign the task to yourself. Check the Rejection Reason Tab of the Change to
understand if a Rework or Reject has been selected.
For tasks under “My Active Tasks” click on
the Part Number to approve the Data
change order and the items.

1.10.2 The purpose of this step for the Site

approver to review and approve changes
done during previous step (i.e.: ‘Define and
Update affected items’ and ‘Review Data
Change’) and to confirm the acceptance.

1.10.3 Approve or reject the task and apply e- On Rejection the workflow moves to “Data change

21
 signature. Approval is a confirmation that Routing” task where the Data Change Coordinator can
the information in the GSK GLAMS system move it back to “Define and update Impacted items”
is correct. task where the initiator can provide
‘Approve’ the task to progress further or clarification/amendments as required and progress the
entire workflow again.
‘Reject’ and select the Reject option under
the “Site Approve Data Change’ tab.

1.11 Approve Data Change

(Role: LOC)
Refer to VQD-WI-055944 - Performing Approval tasks in GSK GLAMS System Instruction
Step Action Additional information
1.11.1 For group tasks, assign the task to yourself. Check the Rejection Reason Tab of the Change to
understand if a Rework or Reject has been selected.

If 3PC Proxy is involved, they provide to 3PC a

screenshot of the updated field.
1.11.2 The purpose of this step for Market
approver is to review and approve changes
done during previous steps and to
confirm they are acceptable from a
regulatory point of view.
1.11.3 Ensure all requested changes have been
executed correctly and are consistent
across the same pack, when applicable.
1.11.4 Ensure that the content of forms (e.g. the
overprint form) is reviewed as well as the
information in the system.
1.11.5 All Approving Markets must be approvers of
their associated components.
If other approvers must be assigned, click
on ‘Rework’ and then liaise with the Data
Change Coordinator to add them.
1.11.6 Should there be any delays to the original
agreed deadlines, raise a Comment
involving CMO/Site and Data Change
Coordinator to agree new Implementation
dates.
1.11.7 Approve or reject the task and apply e- To sign off insert e-signature.
signature. Approval is a confirmation that
the information in the GSK GLAMS system If 3PC Proxy is involved, they approve to record that the
is correct. Change meets 3PC requirements.
‘Approve’ the task to progress further or
‘Reject’ and select the Reject option.

22
1.12 Vx Global Approve Data Change
(Role: Vx Global Function)
Refer to VQD-WI-055944 - Performing Approval tasks in GSK GLAMS System Instruction
Step Action Additional information
1.12.1 For group tasks, assign the task to yourself. Check the Rejection Reason Tab of the Change to
understand if a Rework or Reject has been selected.
For tasks under “My Active Tasks” click on
the Part Number to approve the Data
change order and the items.

1.12.2 The purpose of this step for the Vx Global

approver to review and approve changes
done during previous step (i.e.: ‘Define and
Update affected items’ and ‘Review Data
Change’) and to confirm the acceptance.

1.12.3 Approve or reject the task and apply e- On Rejection the workflow moves to “Data change
signature. Approval is a confirmation that Routing” task where the Data Change Coordinator can
the information in the GSK GLAMS system move it back to “Define and update Impacted items”
is correct. task where the initiator can provide
clarification/amendments as required and progress the
‘Approve’ the task to progress further or entire workflow again.
‘Reject’ and select the Reject option under
the “Site Approve Data Change’ tab.

1.13 Data Change Pre-Library

(Role: Data Change Coordinator)
Refer to VQD-WI-051391 - Performing Review tasks in GSK GLAMS System Instruction
Step Action Additional information
1.13.1 When Data Change is Approved, the If CMO Proxy is involved, Data Change Coordinator
components impacted don’t move to the Coordinator to inform CMO Proxy of Change
library until the Data Change Pre-Library completion.
Task is complete.
If 3PC Proxy is involved, Data Change Coordinator
Coordinator to inform 3PC Proxy of Change completion.
 Click on ‘Move to Library and Notify
Dispatch’ for artwork supplier related In case of Supplier updates, upon completion of Data
changes, system sends a notification to Change Pre-Library Task a notification is sent to
the Dispatch group to dispatch the file to Dispatcher to perform Dispatch. Dispatcher follows
the new supplier(s). VQD-WI-055982-Managing dispatch of files in GSK
GLAMS.
 Click on ‘Move to Library’ for other
components supplier updates. Where When the Data Change Pre-Library task is completed
the data change and all updated items is moved to their
the File Dispatch task is present for respective library. Where a lifecycle value has been
technical drawing and specification updated the updated item must be moved to the library
supplier updates the Data Change File corresponding to the lifecycle value, i.e., Obsolete or
Dispatch task become automatically Divested.

23
 active.

1.14 File Dispatch

(Role: Dispatcher)
Refer to VQD-WI-051392 - Artwork and Packaging Studio Tasks in GSK GLAMS System Instruction
Step Action Additional information
1.14.1 In case of Supplier updates, upon Dispatch. Dispatcher follows VQD-WI-055982 -
completion of ‘Data Change Pre-Library’ Managing dispatch of files in GSK GLAMS.
Task a notification is sent to Dispatcher to
perform ‘File Dispatch’ Task.

1.14.2 In case of Supplier Updates to the Aa a CAD Operator assign the task from the Group
components like DWG/SPEC/NPC items a Tasks. Open the File Dispatch Task and perform the
File Dispatch Task is generated and File Dispatch as per VQD-WI-055982-Managing
assigned to the CAD Operator group. dispatch of files in GSK GLAMS.
Under ‘Data Change File Dispatch’ tab Complete the
task .

2. SKU Change

2.1 Initiate SKU Change

(Roles: LOC, Artwork Coordinator/FASP, 3PC Proxy, CMO/Site/Proxy, Repacker Proxy)
Refer to VQD-WI-051389 - Initiating Changes in GSK GLAMS System Instruction
Step Action Additional information
2.1.1 Create the change, selecting the relevant Note: for Packaging driven SKU Change Site is the
‘New Request’ category. For SKU Change Initiator.
select ‘SKU Change Request’.
If 3PC Proxy is involved they:
 get relevant information from the 3PC, as a
minimum:
o site item code of impacted SKU/PPC
o description of the Change
o 3PC contact and email address
o implementation date
 enter all available information on the VQD-FRM-
097312 GSK GLAMS Third Party Customer (3PC)
Request Form and provide it to 3PC
 If the Change affects Pre-print/Overprint updates,
enter all available information on the VQD-FRM-
067564 GSK GLAMS Pre-print/Overprint Form
and provide it to 3PC (and VQD-WI-051492 How to
Complete the GSK GLAMS Pre-print/Overprint
Form, if required)
2.1.2 Complete the associated fields on the Refer to Appendix 1 – Data and SKU change fields.

24
 Change. Fields with asterisk (*) are required at this stage. Others
can be populated also at next stage.
2.1.3 The ‘Reason for Change’ and the details e.g: for better visibility include the list of existing
of the change required must be clearly component to be added in the new SKU via the
stated. Supplementary Info.
2.1.4 Note: If market owning the PPC is not the
same of the one owning the SKU, Market
not owning the PPC to inform Artwork
Coordinator that a a Data Change after
SKU change is released, to populate
additional market fields in component.
2.1.5 Click on ‘Submit’ to create the change. Take note of the Change ID, as it is needed in the next
SKU Change ID is shown in Part Number step.
field, on top.
2.1.6 ‘Close’ the window to proceed further.

2.2 Define and update impacted SKU

(Roles: LOC, Artwork Coordinator/FASP, 3PC Proxy, CMO/Site/Proxy, Repacker Proxy)
Refer to VQD-WI-051389 - Initiating Changes in GSK GLAMS System Instruction
Step Action Additional information
2.2.1 Select the task. Note: for Packaging driven SKU Change
 this task is performed by Site
 insert ‘Packaging driven’ as Reason for Change to
identify if the SKU Change is packaging driven.

Check the Rejection Reason Tab of the Change to

understand if a Rework or Reject has been selected.

2.2.2 Access the change and in ‘Define and Refer to Appendix 1 – Data and SKU change fields for
update Impacted SKU’ tab, review the the list of fields and how to use them.
fields previously populated, filling in the
missing ones. If 3PC Proxy is involved they:
 fill in the fields as per information received from the
3PC.
 provide to 3PC a screenshot of the updated field.
2.2.3 Ensure the correct value(s) in ‘Reason for
Change’ field is added.
2.2.4 Identify and add affected items (SKUs) to Within the relevant section click on ‘Link’ and run the
the change. SKUs are added in ‘Linked relevant search to identify the affected SKU.
SKU’ section. Once the affected component is identified click on ‘Link’.
2.2.5 Ensure there is consistency between the
Approving and Additional Markets fields at
SKU and Change level.
2.2.6 If the change relates to the creation of new Note: system auto assigns to these new SKU the
component/new SKU, create these using information that are displayed in ‘Perform Change
‘Create New Component’ or ‘Create New Impact Assessment’ tab, this information can be edited
SKU’ functionality, the system generates as appropriate.
placeholders for these components.

25
 For Packaging Driven SKU Change where a new SKU is
created, Site is responsible to insert the SKU "Site Item
Code", "Packaging Platform" and "Description".
2.2.7 Check any pending changes which can
be combined. If not possible, avoid
progressing new changes until the
previous change is released.
2.2.8 In the ‘Documents’ tab of the Upload overprint form in the Documents Tab of the SKU.
Change/SKU, add any supporting
document that relates to the Change and If a new Overprint/braille is to be added due to rework,
not the single components. Select the ensure it is clearly identified including version and that
the site have been made aware this version supersedes
correct Category that applies. the version.

If 3PC Proxy is involved, they attach:

 filled GLAMS 3PC Request Form.
 If the Change affects Pre-print/Overprint, the filled
GLAMS Pre-print/Overprint Form.
2.2.9 Create a Comment and involve required
parties to discuss any pending point.
Comment related to Implementation Date
must involve Artwork Coordinator and
CMO/Site.
2.2.10 Ensure the correct Artwork Coordinator is
assigned to the ‘Artwork Coordinator’
field in the Change.
2.2.11 For each affected SKU perform the Refer to Appendix 2 - SKU and component fields for
following, to update the relevant the list of fields and how to use them.
information:
GSK Site to follow VQD-SOP-079338 - How to Create
Access each component via ‘Edit SKU’
and Maintain a BOM in GSK GLAMS.
functionality to edit the required fields and
update data and/or BOM as required. Via Nested Intermediates can be built at this task. In order to
the ‘Edit SKU’ option it is possible to link do so include all the SKUs that are part of the nested
component to the SKU. BOM as affected items to the Linked SKU Grid.
Fields of new SKU can be edited here;
ensure information previously entered at From the affected SKU items, edit a SKU item and link
change level are aligned accordingly. the child SKU in the “Linked Child SKUs” grid by using
the “Link” function.
In case of Intermediates within Site, the Secondary Site
Name must be the same as the Site Name.

2.2.12 Go back to ‘Define and update Impacted Click on ‘Cancel’ to cancel the Change, in case it is no
SKU’ task and click on Submit to proceed longer used.
further.

2.3 SKU Change Routing

(Role: Artwork Coordinator/FASP)
Refer to VQD-WI-051390 - Performing Routing task in GSK GLAMS System Instruction

26
Step Action Additional information
2.3.1 For group tasks, assign the task and change Check the Rejection Reason Tab of the Change to
the Job Owner to yourself. understand if a Rework or Reject has been selected.

2.3.2 Access Change Routing panel and navigate Information about the change can also be accessed via
to the Change to review change information ‘Job Info’ option on the right.
and SKU information entered by the initiator.
If any information is incorrect/not complete,
liaise with the initiator of the change to
complete. Rework can be triggered at this
stage, if required.
2.3.3 Select relevant Template depending on the If Standard SKU Change
scenario (‘SKU_Change_Standard_Template’) is selected:
completion of ‘SKU Change Routing’ triggers the
Approving Markets/Central Functions Review tasks,
followed by Site Provide SKU and BOM details tasks
and then by Approving Markets/Central Functions
Approval tasks. Refer to steps from 2.4 to 2.7.

If Packaging SKU Change

(‘SKU_Change_Site_Initated_Template’) is selected:
completion of ‘SKU Change Routing’ triggers the
Approving Markets/Central Functions Review tasks,
followed by Site and Vx Global Function Approval
task. Refer to steps from 2.8 to 2.11.
2.3.4 If the pack is supplied to one Approving
Market only, and they initiated the change,
agree with them whether a further task for
Review SKU Change Task is needed; if not,
cancel it.
2.3.5 Check change/component information
versus information on title block of SKUs, to
ensure there is at least an task for each:
• Approving Market (if they appear on title
block in ‘Approving Markets’ field)
• Central Approving function (if they appear
on title block as ‘Central Approving
Function’) – manual task addition required.
• Site (as they appear in Artwork Details Tab,
Artwork – General Information section field of
components)
• Additional Market (if they appear in title Note: Additional Market Approval Task isn’t created as
block as ‘Additional Markets’ and ‘Additional the “Additional Market Review Change” of Pack
Market Pending Acceptance’)– manual task Change - no Accept/Decline option available.
creation is required.
• All Market driven Data Changes MUST have
the Approving Market(s) as an Approve.r
• If the product is dual sourced (supplied by
different sites) then each site must be
included in the plan.
2.3.6 If Additional Market/s are involved, manually

27
 add a Review SKU Change and a Approve
SKU Change Task for each Additional
Market.
2.3.7 Assigns Users who will be involved the For Third Party Customer (3PC) keep only the 3PC
change and check the relevant resource “Review SKU Change” and “Approve SKU Change”
group. Tasks. Delete the specific Country “Review SKU
Change” and “Approve SKU Change” Tasks (e.g.: keep
3PC Biogaran Tasks and remove France Tasks).
Add additional boxes if more tasks are
required (e.g.: if Additional Market approval
is needed), ensuring relationship are built
accordingly, in the plan.
2.3.8 Adjust task lead-time accordingly. Standard Review the timeline in the plan to ensure milestones
lead-times are entered by the system, but are aligned to the deadlines for the change (or best
they can be updated depending on the estimate of deadlines if they are not available at this
scenario/specific business needs. point).
2.3.9 Check the ‘Documents’ tab of the Overprint form is uploaded in the Documents Tab of the
Change/SKU If a new Overprint/braille is to SKU.
be added due to rework, ensure it is clearly
identified including version and that the site
have been made aware this version
supersedes the version.
2.3.10 Consider any Comment raised during
previous stages and if they are resolved.
2.3.11 Facilitate and reflect any agreements
regarding the dates between the relevant
parties, ensure the change is aligned to the
agreed dates and the same are reflected in
the associated date fields. Comments
related to Implementation date must involve
LOC(s) and CMO/Site.
2.3.12 Create a Comments, if needed, and involve
required parties to discuss any pending
point.
2.3.13 ‘Submit’ the task to proceed further or
‘Rework’ to move back the Change to
‘Define and update affected SKU’ Task.

Standard SKU Change

2.4 Review SKU Change

(Roles: LOC, GRA, GSC Medical Device, 3PC Proxy)
This step applies when Approving Markets are associated to SKU and components.
Refer to VQD-WI-051391 - Performing Review tasks in GSK GLAMS System Instruction
Step Action Additional information

28
2.4.1 For group tasks, assign the task to yourself. Check the Rejection Reason Tab of the Change to
understand if a Rework or Reject has been selected.

If 3PC Proxy is involved and the SKU Change is not

initiated by 3PC Proxy and/or if there are other
Approving Markets/Central Function involved, 3PC
Proxy to:
 provide to 3PC details on the update done via Data
Change.
 provide to 3PC a screenshot of the updated field
2.4.2 Access the change and in ‘Review Change’ Refer to Appendix 1 – Data and SKU change fields
tab, review the fields previously populated for the list of fields and how to use them
(fields and documents attached) filling in the
missing ones. Ensure that any information
relevant to your role is correct.
2.4.3 Ensure the correct value(s) in ‘Reason for
Change’ field is added.
2.4.4 Review of information only is required if Full provision of information is required if Approving
Approving Market is the one initiating the Market was not the initiator (e.g., multimarket pack) - for
change. instructions refer to ‘Define & Update Impacted Items’
step).
2.4.5 Add/review supporting documents in Overprint form is uploaded in the Documents Tab of the
‘Documents’ tab of the Change/SKU SKU.
2.4.6 If any information is missing, send a
Comment to Artwork Coordinator and Market
stating which information is missing. Create a
Comment, if needed, and involve required
parties to discuss any pending point.
Comments related to dates must involve
LOC(s), Artwork Coordinator and CMO/Site.
2.4.7 For each affected SKU perform the following, Refer to Appendix 2 - SKU and component
to update the relevant information: fields
Review the SKUs added to the change.
Update Change fields as required.
If required, additional SKUs can be added at
this stage. In this instance, create a
Comment to involve Artwork Coordinator and
any other LOC, and trigger a rework back to
involve the remaining Approving Market.
System requires a reason for rework to be
entered before routing the change back.
2.4.8 Go back to ‘Review Data Change’ task and
complete to proceed further. Click on
‘Rework’ if any amendment is needed.

29
2.5 Provide SKU and BOM Details
(Roles: CMO/Site/Proxy, Repacker Proxy)
Refer to VQD-WI-051391 - Performing Review tasks in GSK GLAMS System Instruction
Step Action Additional information
2.5.1 For group tasks, assign the task to yourself. Check the Rejection Reason Tab of the Change to
understand if a Rework or Reject has been selected
2.5.2 Access the change and in ‘Provide SKU Refer to Appendix 1 – Data and SKU change fields
and BOM details’ tab, review the fields for the list of fields and how to use them.
previously populated, filling in the missing
ones. Ensure that any information relevant If CMO Proxy is involved they:
 fill in the fields as per information received from
to your role is correct.
the CMO.
 In case creation of new SKU is required,Proxy to:
o get from CMO confirmation that components
proposed by LOC are acceptable.
o provide to CMO screenshot of LOC
requirements.
o refer to Appendix 2 - SKU and component
fields to retrieve the CMO owned field
information
 once all information are filled in in GSK GLAMS,
send screenshot to CMO of the updated item.

If Repacker Proxy is involved they include relevant

details as per information received from the Repacker.
2.5.3 Ensure the correct value(s) in ‘Reason for If any update is required, Rework and route the Change
Change’ field is added. back to Routing.
2.5.4 Review the SKUs added in ‘Linked SKU’
section
2.5.5 If the change relates to the creation of new Note: system auto assigns to these new components
SKU, create these using ‘Create New SKU’ the information that are displayed in Perform Change
functionality; system generates placeholders Impact Assessment tab, this information can be edited
for these components. as appropriate.
If a new component is added, ensure to
trigger a rework phase for Artwork
Coordinator to involve again Markets.
2.5.6 In ‘Documents’ tab of the Change/SKU, Overprint form is uploaded in the Documents Tab of the
review/add any supporting document to the SKU.
change that relates to the Change and not
the single components. Select the correct
Category that applies.
2.5.7 Ensure there is consistency between the
Approving and Additional Markets fields at
SKU and Change level.
2.5.8 Create a Comment and involve required
parties to discuss any pending point.
Comment related to dates must involve
Artwork Coordinator and CMO/Site.
2.5.9 For each affected SKU perform the Note: the GSK GLAMS SKU is a static SKU and

30
 following, to update the relevant information: hence all updates done via the Change will be
Access each component via ‘Edit SKU’ reflected immediately in the SKU Library. The
functionality to edit the required fields and source of truth for SKU and BoM details is the Site
update BoM. Via the ‘Edit SKU’ option it is System.
possible to link component to the SKU Refer
to Appendix 2 - SKU and component GSK Site to follow VQD-SOP-079338 - How to Create
fields and Maintain a BOM in GSK GLAMS
Fields of new components can be edited
here; ensure information previously entered
at change level are aligned accordingly.
2.5.10 Review the Market proposed updates and
confirm if that is ok (e.g.: check the PPC
Market has added to the SKU). If any update
is required, Rework and route the Change
back to Routing.
2.5.11 Go back to ‘Provide SKU and BOM details’
task and click on ‘Complete’ to proceed
further. Click on ‘Rework’ if any amendment
is needed.

2.6 Approve SKU Change

(Roles: LOC, GRA, GSC Medical Device, 3PC Proxy)
Refer to VQD-WI-055944 - Performing Approval tasks in GSK GLAMS System Instruction
Step Action Additional information
2.6.1 For group tasks, assign the task to yourself. Check the Rejection Reason Tab of the Change to
understand if a Rework or Reject has been selected.

If 3PC Proxy is involved, they provide to 3PC a

screenshot of the updated field.
2.6.2 Market to check the final structure of the SKU
with associated PPC and any applicable meta
data. The purpose of this step for Market
approver is to review and approve changes
done during previous step (i.e.: Define and
Update affected items and Review Data
Change) and to confirm they are acceptable
from a regulatory point of view.
2.6.3 Ensure all requested changes have been
executed correctly and are consistent across
the same pack.
2.6.4 Ensure that the content of forms (e.g. the
overprint form) is reviewed as well as the
information in the system.
2.6.5 Approve or reject the task and apply e- All Approving Markets/Central Approving Functions
signature. Approval is a confirmation that the must be approvers of their associated components.
information in the GSK GLAMS system is If other approvers must be assigned, click on Rework
correct. and then liaise with the Artwork Coordinator to add
them.
Should there be any delays to the original

31
 agreed deadlines, raise a Comment involving
Site and Artwork Coordinator to agree new
dates.
2.6.6 ‘Approve’ the task to progress further or To sign off insert e-signature.
‘Reject’ and select the Reject option.
If 3PC Proxy is involved, they approve to record that
the Change meets 3PC requirements.

2.7 SKU Change Pre-Library

(Role: Artwork Coordinator/FASP)
Refer to VQD-WI-051391 - Performing Review tasks in GSK GLAMS System Instruction
Step Action Additional information
2.7.1 When SKU Change is Approved, the updated If CMO Proxy is involved, Artwork Coordinator to inform
SKU is moved to the library but to complete CMO Proxy of Change completion.
the overall Change the following step is
needed: click on ‘Move to Library’ to release If 3PC Proxy is involved, Artwork Coordinator to inform
3PC Proxy of Change completion.
the change to the SKU Change Library.
If Repacker Proxy is involved, Artwork Coordinator to
inform Repacker Proxy of Change completion.

Packaging SKU Change

Note: first 3 Tasks (Initiate SKU Change, Define and Update impacted SKU, SKU Change Routing) and
associated instructions are the same of the Standard SKU Change.

2.8 Review SKU Change

(Roles: LOC, GRA, GSC Medical Device, 3PC Proxy)
This step applies when Approving Markets are associated to SKU and components.
Refer to VQD-WI-051391 - Performing Review tasks in GSK GLAMS System Instruction
Step Action Additional information
2.8.1 For group tasks, assign the task to yourself. Check the Rejection Reason Tab of the Change to
understand if a Rework or Reject has been selected.

If 3PC Proxy is involved and the SKU Change is not

initiated by 3PC Proxy and/or if there are other
Approving Markets/Central Function involved, 3PC
Proxy to:
 provide to 3PC details on the update done via Data
Change.
 provide to 3PC a screenshot of the updated field
2.8.2 Access the change and in ‘Review Change’ Refer to Appendix 1 – Data and SKU change fields
tab, review the fields previously populated for the list of fields and how to use them
(fields and documents attached) filling in the
missing ones. Ensure that any information
relevant to your role is correct.
2.8.3 Ensure the correct value(s) in ‘Reason for

32
 Change’ field is added.
2.8.4 Review of information only is required if Full provision of information is required if Approving
Approving Market is the one initiating the Market was not the initiator (e.g., multimarket pack) - for
change. instructions refer to ‘Define & Update Impacted Items’
step).
2.8.5 Add/Review supporting documents in Overprint form is uploaded in the Documents Tab of the
‘Documents’ tab of the Change/SKU. SKU.
2.8.6 If any information is missing, send a
Comment to Artwork Coordinator and Market
stating which information is missing. Create a
Comment, if needed, and involve required
parties to discuss any pending point.
Comments related to dates must involve
LOC(s), Artwork Coordinator and CMO/Site.
2.8.7 For each affected SKU perform the following, Refer to Appendix 2 - SKU and component fields
to update the relevant information:
Review the SKUs added to the change.
Update Change fields as required.
If required, additional SKUs can be added at
this stage. In this instance, create a
Comment to involve Artwork Coordinator and
any other LOC, and trigger a rework back to
involve the remaining Approving Market.
System requires a reason for rework to be
entered before routing the change back.
2.8.8 Go back to ‘Review Data Change’ task and
complete to proceed further. Click on
‘Rework’ if any amendment is needed.

2.9 Site Approve SKU Change

(Role: Site)
Refer to VQD-WI-055944 - Performing Approval tasks in GSK GLAMS System Instruction
Step Action Additional information
2..9.1 For group tasks, assign the task to yourself. Check the Rejection Reason Tab of the Change to
understand if a Rework or Reject has been selected.
For tasks under “My Active Tasks” click on
the Part Number to approve the SKU change
order and the items.

2.9.2 The purpose of this step for the Site approver Under the “Approve SKU Change” review and
to review and approve changes and to approve the change details
confirm the acceptance.
Under the “Linked SKU” grid, click on each SKU item
and review and approve the SKU attributes, review and
approve the items linked under “Linked Items”
2.9.3 Review supporting documents in
‘Documents’ tab

33
2.9.4 Approve or reject the task and apply e- On Rejection the workflow moves to “SKU change
signature. Approval is a confirmation that the Routing” task where the Artwork Change Coordinator
information in the GSK GLAMS system is can move it back to “Define and update Impacted
correct. SKUs” task where the initiator can provide
clarification/amendments as required and progress the
‘Approve’ the task to progress further or entire workflow again.
‘Reject’ and select the Reject option under
the “Approve SKU Change’ tab.

2.10 Vx Global SKU Change Approval

(Role: Vx Global Function)
Refer to VQD-WI-055944 - Performing Approval tasks in GSK GLAMS System Instruction
Step Action Additional information
2.10.1 For group tasks, assign the task to yourself. Check the Rejection Reason Tab of the Change to
understand if a Rework or Reject has been selected.
For tasks under “My Active Tasks” click on
the Part Number to approve the SKU change
order and the items.

2.10.2 The purpose of this step for the Vx Global Under the “Approve SKU Change” review and
Function approver to review and approve the change details
approve changes and to confirm the
acceptance. Under the “Linked SKU” grid, click on each SKU item
and review and approve the SKU attributes, review and
approve the items linked under “Linked Items”
2.10.3 Review supporting documents in
‘Documents’ tab

2.10.4 Approve or reject the task and apply e- On Rejection the workflow moves to “SKU change
signature. Approval is a confirmation that the Routing” task where the Artwork Change Coordinator
information in the GSK GLAMS system is can move it back to “Define and update Impacted
correct. SKUs” task where the initiator can provide
clarification/amendments as required and progress the
‘Approve’ the task to progress further or entire workflow again.
‘Reject’ and select the Reject option under
the “Approve SKU Change’ tab

2.11 SKU Change Pre-Library

(Role: Artwork Coordinator/FASP)
Refer to VQD-WI-051391 - Performing Review tasks in GSK GLAMS System Instruction
Step Action Additional information

34
 2.11.1 When SKU Change is Approved, the If CMO Proxy is involved, Artwork Coordinator to
updated SKU is moved to the library but to inform CMO Proxy of Change completion.
complete the overall Change the following
step is needed: click on ‘Move to Library’ to If 3PC Proxy is involved, Artwork Coordinator to inform
3PC Proxy of Change completion.
release the change to the SKU Change
Library.

THIS IS THE END OF THE ‘Progress Data Change and SKU Change in GSK GLAMS’ DOCUMENT.

Training Requirement(s)
The requirement to read/record this SOP is defined by the APS Curricula.
For this document version refer to the table below.

Document Update Training Requirements Type Selected

Type
Doc Update Type 1 There is no read/record requirement for this document
version.
Doc Update Type 2 There is a read and record requirement for this version of
the document. Read and record for this version has been
managed through the completion of the Document Update
Summary.
Doc Update Type 3 There is a read and record requirement for this version of
the document.

Reference(s)
The documents and links below are related to this SOP.

Document Number Document Title Document Type

VQD-REF-004217 APS system and process glossary REF
VQD-SOP-015866 Divestment Process SOP

35
Document Number Document Title Document Type
VQD-SOP-072496 Progress an artwork change in GSK GLAMS SOP
VQD-SOP-072498 Managing Vendors in GSK GLAMS SOP
Additional guidance on artwork change scenarios in GSK
VQD-WI-051469 WI
GLAMS
How to manage Intermediates between a CMO in GSK
VQD-WI-051468 WI
GLAMS and a GSK Site in Harmony
Understanding item status and lifecycle phases in GSK
VQD-WI-051491 WI
GLAMS
VQD-FRM-067564 GSK GLAMS Pre-print/Overprint Form TMP
VQD-WI-051492 How to Complete the GSK GLAMS Pre-print/Overprint WI
Form
VQD-FRM-097312 GLAMS 3PC Request Form TMP
VQD-SOP-079525 How to progress a Non-Printed Component Change in SOP
GSK GLAMS
VQD-SOP-079337 How to Progress a Drawing Change in GSK GLAMS SOP
VQD-SOP-079336 How to Progress a Specification Change in GSK GLAMS SOP
VQD-SOP-072498 Managing Vendors in GSK GLAMS SOP
VQD-SOP-079715 Progress Studio Assets in GSK GLAMS SOP
VQD-SOP-079338 How to Create and Maintain a BOM in GSK GLAMS SOP
VQD-WI-055982 Managing dispatch of files in GSK GLAMS WI
Appendices

Appendix 1 – Data and SKU Change fields

Fields marked with * are required by the system to progress to the next step

The entry Site in the Owner column below may refer to CMO, GSK Site, Repacker.

GSK GLAMS field Definition Owner GSK GLAMS Step

Change Description A brief summary description of the change. Market/Site This field is required at Initiate
Change*, it can edited until
Approve Data/SKU Change
Supplementary Any additional information that will assist Market/Site This can be entered at Initiate
information implementation of the change. Change and edited until
Approve Data/SKU Change
Business Area Classification of the product business area Market This can be entered at Review
Data/SKU Change
Reason for Change It categorises the reason(s) for initiating the Market/Site This can be entered at Initiate
change. All applicable values must be Change and edited until
added. Approve Data/SKU Change
Ensure, if one of the following is the reason
for raising the change, that this is added in
the field, as it is critical:
 Storage Conditions/ Shelf-life change
(only if overprint are impacted)

36
  Pre-print/Overprint changes
 Changes in pack/leaflet related to
addition/removal/change of medical
device
 Manufacturers/Releasers/MAH changes
 Update of registration number
Approving Markets Market(s) affected by the project Market/Artwork This field is required at Initiate
Coordinator Change*, it can be edited until
Data/SKU Change Routing.
If no Approving Market are
present (e.g.: GEXP) the field
must be filled in with N/A
Central Approving Pack owned any approved by the central Market/Artwork This can be entered at Initiate
Function functions like GRA, GSC Medical Device etc. Coordinator Change and edited until
Data/SKU Change Routing
Additional Markets List of all additional markets (or groups) that Market/Artwork This can be entered at Initiate
will be affected by this change. Coordinator/Site Change and edited until Data
Change Routing
Site(s) Name Lists the GSK manufacturing site(s) or the Market/Artwork This field is required at Initiate
3rd Party Contract Manufacturers that will be Coordinator Change*, it can be edited until
affected by the change. Data/SKU Change Routing
Implementation Change Implementation Date. Site This can be entered at Initiate
Date Expected date by when the Change is fully Change, but can be edited
approved and released in the artwork system until Approve Data/SKU
Change
Artwork Coordinator Person who is responsible for ensuring the Market/Site This field is required at Initiate
(for SKU Change Change happens effectively and resolves Change*
only) issues and conflicts (FASP, Artwork
Coordinator, Artwork project specialist).

Data Change Person who is responsible for ensuring the Market/Site This field is required at Initiate
Coordinator (for Change happens effectively and resolves Change*
Data Change only) issues and conflicts (e.g.: Pack Techologist,
Artwork Coordinator, FASP)
Job Owner Owner of the Change Artwork This field is system generated.
Coordinator At Change and Artwork
Routing the Job Owner is
updated by Artwork
Coordinator.
Updates to Job Owner at step
not assigned to the Artwork
Coordinator can be done via
the Tracker.

Appendix 2 – SKU and component fields

SKU GSK GLAMS fields

Note:

37
• For existing SKU: Secondary Site Item code, Risk Print, Product Characteristics and CRSF Requirement
fields are editable within a Pack Change. All other SKU attributes are editable only via SKU or Data
Change.

• For new SKU: all attributes are editable within a Pack Change or SKU/Data Change.

The entry Site in the Owner column below may refer to CMO, GSK Site, Repacker.

GSK GLAMS SKU field Description Owner

Description Site description, aligned with local manufacturing System. Site
Site Item code Site code, aligned with local manufacturing System. Site
Package Level Hierarchical Position of each Component within BOM. Site
GTIN/NTIN The GTIN/NTIN is the unique number to identify the Market
registered product (sale unit). Refer to Sale Unit only. If
Serialized is YES, provide the GTIN otherwise leave it
blank.
Approving Markets List of Markets approving the Artwork. Market
Dosage Form Physical form of a dose of a chemical compound used as Market
a drug or medication intended for administration or
consumption. E.g.: Capsule, Gel, Syrup, Tablet.
Business Area Classification of the product business area. Market
For new pack change where new SKU is created, this
information can be entered at Change Initiation.
To be entered/checked at Change Review, when SKU is
linked to the change and/or at Approving Market review
Change.
Product Name Market Name of the product. Market
For new pack change where new SKU is created, this
information can be entered at Change Initiation.
To be entered/checked at Change Review, when SKU is
linked to the change and/or at Approving Market review
Change.
Product Characteristics Identify the main features of finished product, select one Market/Site
or more features.
Packaging Platform Pack Form the pack is delivered like Blister, Bottle, Vial, Site
Ampoule etc.
Site Name Lists the GSK manufacturing site(s) or the 3rd Party Site
Contract Manufacturers that will be affected by the
change.
Sharing Site Name Site that is sharing the component with the main site. Site
Secondary Site Name Manufacturing site Name for Intermediates. Site
In case of Intermediates within Site, the Secondary Site
Name must be the same as the Site Name.
Secondary Site Item Manufacturing site Item code for Intermediates. Site
Code
Dual Sourced Identifies Dual Sourced Product; Two sites with their own Market
SKU and BOM that supply the same presentation of a
product to a market.
Risk Print Identifies if a component is to be risk printed and can be Site (upon agreement with
edited at Site Approval Market)

38
 Serialized Identifies a serialized product Market
Yes/No;
Rule: If Serialized = Yes User enter GTIN.
Product Strength Strength and strength unit of the product as described in Market
pack (e.g. 250mg)
Central Approving Capture the approval of the central functions like GRA, Market
Function GSC Medical Device etc.
Product Family Product Family the Product belongs to. Market
Under Divestment Identifies if a product is under Divestment New Business & Divestment
The NB&D Team will decide if the Product is under Team
Divestment.
Lifecycle Phase Item Lifecycle status: Market/New Business &
 Approved Divestment Team/Site
Indicates the item is approved but not necessarily yet
supplied.The first supply date will be managed by the
site manufacturing system
 Divested
Used when the market authorisation holder has
changed from GSK due to a divestment
 Obsolete
Select when an item is no longer in use
CRSF Requirement (this Select if Child Reistance/Senior Friendly for primary Site
field is business required) component of finished product (e.g.: Lidding foil for
blister, Cap for bottle) is required and implemented
CRSF Certificate CRSF certificate number Site
Number
Count per Primary Pack Number of Dosage Form per each Primary Pack Site
e.g.: 10 Tablets per Blister
Primary Packs per Number of Primary Pack (e.g.: Blister, Device, Holding Site
Carton Container with Active Ingredient) per each Carton
e.g.: 3 Blisters per carton
Finished Pack Quantity The amount of product included in a sales finish pack Site
Pack size of the consumer unit e.g., 24
Unit of Finished Pack Unit of measure of Finished Pack Quantity e.g.: ea, ml Site
Quantity For discrete dose forms like tablets or capsules it will be
counted by product eaches (Count of Tablets), for
dispensed dose products it will be counted by product
doses, for continuous dose forms like liquids or creams it
will be counted in grms or ml.

PPC GSK GLAMS fields:

GSK GLAMS PPC field Description Owner

Risk Print Identifies if a component is to be risk printed. Site (upon agreement with
Market)
Description A literal description of the item, aligned with local Site
manufacturing System.
Component Sub Type Sub type of the packaging item (e.g. ampoule, label, Market/Site
case)

39
Site Item code Manufacturing site Item code or Local Item Code for a Site
CMO/Site
Package Level Hierachical Position of each Component within BOM Site
Approving Markets Markets approving the pack Market
Additional Markets Additional markets Ready taking the pack approved by Artwork Coordinator
the main market
Additional Market Additional markets Non Ready to take the pack Artwork Coordinator
Pending Acceptance approved by the main market yet

Component Identify the main features of packaging item (e.g. Anti Market/Site
Characteristics Counterfeiting, Embossed Decoration, Pre-Assembly,
Serialised, Shared Pack): select one or more features.
Site Name Lists the GSK manufacturing site(s) or the 3rd Party Site
Contract Manufacturers that will be affected by the
change.
Sharing Site Name Site that is sharing the component with the main site. Site
Languages Named languages used in artwork e.g English; French Market
Point of Sale Barcode Point of Sale Barcode Type. Note: multiple types can Market
Type be selected
Point of Sale Barcode Point of Sale Barcode Number. Market
Number
Number of Security Number of security codes contained in artwork -Choose Site
Codes a number 1-5.
Security Code Type Security Type Site
Note: multiple types can be selected.
Security Code Number Security Code Number. Site
Braille Does artwork contain Braille? yes/no Market
Regulatory Minimum Regulatory Minimum Font Size. Market
Font Size
Central Approving To capture the approval of the central functions like Site
Function GRA, GSC Medical Device etc.
Lifecycle Phase Item Lifecycle status: Market/New Business &
 Approved Divestment Team/Site
Indicates the item is approved but not necessarily
yet supplied – The first supply date will be
managed by the site manufacturing system
 Divested
Used when the market authorisation holder has
changed from GSK due to a divestment
 Obsolete
Select when an item is no longer in use
Dimensions Unit Unit of measure for component physical dimensions Site
(e.g.: length, width, height, diameter)
Packed Product Width Width of final single packed product by using a printed Site
flexible component (e.g.: Foil for Blister, Pouch, Sachet,
Stickpack, Strip)
Packed Product Length Length of final single packed product by using a printed Site
flexible component (e.g.: Foil for Blister, Pouch, Sachet,
Stickpack, Strip)
Weight Unit Unit of measurement for the weight (e.g.: Grams (g)) Site

40
 Weight Weight of packaging component Site
Supplier Name Name of the Supplier Site
Printing Process The printing process used for this printed component Site

Forming Technology Technology used by the supplier for forming the Site
packaging component starting from the raw material
(e.g.: Blow moulding, injection moulding,
thermoforming)

NPC GSK GLAMS fields:

GSK GLAMS NPC field Description Owner

Lifecycle Phase Lifecycle status of Non-Printed Component Site
Site Name Lists the GSK manufacturing site(s) or the 3rd Party Site
Contract Manufacturers that will be affected by the
change.
Description A literal description of the item, aligned with local Site
ERP.
Component Sub Type Sub type of the packaging item (e.g. ampoule, label, Site
case)
Sharing Site Name Site that is sharing the component with the main site Site
Site Item code Manufacturing site Item code from Manufacturer Site
Tab
Package Level Hierachical Position of each Component within Site
BOM
Weight Unit Unit of measurement for the weight (e.g. Grams (g)) Site
Weight Weight of packaging component Site
Component Identify the main features of packaging item (e.g. Site
Characteristics Anti Counterfeiting, Embossed Decoration, Pre-
Assembly, Serialised, Shared Pack): select one or
more features.
Forming Technology Technology used by the supplier for forming the Site
packaging component starting from the raw material
(e.g. Blow moulding, injection moulding,
thermoforming)
Supplier Name Name of the Supplier Site

DWG GSK GLAMS fields:

GSK GLAMS DWG field Description Owner

Lifecycle Phase Lifecycle status of Drawing Site Pack Tech
Type of Drawing Attribute to differentiate if it is a Non Production or a Site Pack Tech
production drawing.
Site Name Lists the GSK manufacturing site(s) or the 3rd Party Site Pack Tech
Contract Manufacturers that will be affected by the
change.
Description A literal description of the item, aligned with local Site Pack Tech

41
 ERP.
Component Sub Type Sub type of the packaging item (e.g. ampoule, label, Site Pack Tech
case)
Sharing Site Name Site that is sharing the component with the main site Site Pack Tech
Site Item code Manufacturing site Item code from Manufacturer Site Pack Tech
Tab
Format Complexity Comment to justify the complexity status assigned Site Pack Tech
Comment to the supply chain item (Format/Shape of a
component).
Component Style Describe the form, fit, function and style (shape) of Site Pack Tech
packaging components, for reel material, describe
the cold or thermal forming of the material to a
finshed packaging components, eg. Cold forming of
pouch, thermal forming of blister, heat
shrinkwrapping, heat shrinking of sleeves
Dimensions Unit Unit of measure for component physical dimensions Site Pack Tech
(e.g. length, width, height, diameter)
External Width External width of packaging component Site Pack Tech
Diameter The diameter of a circular component body, or neck, Site Pack Tech
screw thread, orifice
Neck Size The outside neck diameter of an holding container Site Pack Tech
having crimp or screw neck (e.g. bottle, vial)
Neck Diameter Diameter of an holding container, different from the Site Pack Tech
neck size (e.g. neck diameter where an ampoule is
broken)
Folded Length The length of a folded leaflet Site Pack Tech
Folded Width The width of a folded leaflet Site Pack Tech
Folded Height The height of a folded leaflet Site Pack Tech
Capacity Unit Filling volume for a container, normally for liquid, Site Pack Tech
colloidal, gel or paste volume
Brimful capacity Overflow filling volume, ie, the overflowing volume of Site Pack Tech
the component (container)
External Length External length of packaging component or packed Site Pack Tech
product
External Height External height of packaging component or packed Site Pack Tech
product
Reel Width The width of a packaging material wound on a reel Site Pack Tech
(e.g. Film, Foil, Leaflet, Sleeve)
Thread Diameter The outside (external) diameter of threads delimiting Site Pack Tech
the height of the thread profile (crest) in a container
with screw neck or a screw closure
Wall Thickness Thickness of the holding container wall: it is the Site Pack Tech
difference between the external diameter and
internal diameter of the container body
Internal Length Internal length of packaging component or packed Site Pack Tech
product
Internal Width Internal width of packaging component or packed Site Pack Tech
product
Internal Height Internal height of packaging component or packed Site Pack Tech
product
Nominal Capacity Nominal Volume indicated by the manufacturer that Site Pack Tech
represents the maximum recommended filling level

42
 in an holding container
Dosing Mark Description Volume of dosing mark moulded or printed on the Site Pack Tech
dosing device, eg, measuring cup, spoon,
Perforation Refer to any perforated line applied to the packaging Site Pack Tech
component during its manufacturing process along
its surface
Distance Between Labels The distance from label to label when they are over Site Pack Tech
the reel, measured in the unwidinging direction
Reel Max Diameter (mm) The maximum external diameter size allowed for Site Pack Tech
the reel of a packaging component (ie label,
leaflet,..), to ensure it fits at the packagign
equipment labeller.
Core Diameter (mm) The internal diameter of the reel of a packaging Site Pack Tech
component (ie label, leaflet,..) at the level of the
core
Supplier Name Name of the Supplier Site Pack Tech
Reverse Print Reverse Print Site Pack Tech
Joint Type Joint Type Site Pack Tech
FEFCO Design Style FEFCO Design Style Site Pack Tech

GENERAL SPEC GSK GLAMS fields:

GSK GLAMS GEN SPEC Description

Owner
field
Lifecycle Phase Lifecycle status of General Specification Site Pack Tech
Site Name Lists the GSK manufacturing site(s) or the 3rd Site Pack Tech
Party Contract Manufacturers that will be affected
by the change.
Description A literal description of the item, aligned with local Site Pack Tech
ERP.
Sharing Site Name Site that is sharing the component with the main Site Pack Tech
site
Site Item code Manufacturing site Item code from Manufacturer Site Pack Tech
Tab
Component Sub Type Sub type of the packaging item (e.g. ampoule, Site Pack Tech
label, case)
Supplier Name Name of the Supplier Site Pack Tech

MATERIAL SPEC GSK GLAMS fields:

GSK GLAMS MAT SPEC Description

Owner
field
Lifecycle Phase Lifecycle status of Material Specification Market / New Business &
Divestment Team
Site Name Lists the GSK manufacturing site(s) or the 3rd Site Pack Tech

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 Party Contract Manufacturers that will be affected
by the change.
Description A literal description of the item, aligned with local Site Pack Tech
ERP.
Component Sub Type Sub type of the packaging item (e.g. ampoule, Site Pack Tech
label, case)
Sharing Site Name Site that is sharing the component with the main Site Pack Tech
site
Site Item code Manufacturing site Item code from Manufacturer Site Pack Tech
Tab
Material Complexity Comment Comment to justify the complexity status assigned Site Pack Tech
to the supply chain item (Starting Material used to
manufacture a component).
Packaging Material The list Site Pack Tech
- Material type (Paper, Glass, plastic)
- Material (HDPE, PP, GC2 cartonboard)
- Material grade (Purell 2420F, ) Corrugate Spec
example for material i.e. K140/ 140SC/ K140
- Resin name
Packaging Sub Material Sub Material of the packaging item e.g., 40gsm Site Pack Tech
bleached kraft paper/12gsm LDPE/8 micron Alu
foil/23 gsm LDPE
Number of Layers Number of layers for packaging material Site Pack Tech
Layer Name Multi layers information like - Outer layer, Inner Site Pack Tech
layer etc
Material Type Multi layers packaging material Site Pack Tech
Thickness/Grammage Thickness/Grammage of multi layer packaging Site Pack Tech
material
% of the Total Weight % Weight of Packaging material in total weight Site Pack Tech
Material Colour Colour of raw material (e.g. facestock of adhesive Site Pack Tech
web) used to manufacture the packaging
component
Thickness UoM Thickness units of measure Site Pack Tech
Adhesive Type The type of adhesive used in the self adhesive Site Pack Tech
label
Flute Fluting grade, denoting the gap of the corrugation Site Pack Tech
between inner and outer liner of a corrugated
case, corrugated tray. Usually expressed by a
letter (e.g. B, C, E)
Master Batch / Colourant Concentrated mixture of pigments and/or additives Site Pack Tech
encapsulated during a heat process into a carrier
resin which is then cooled and cut into a granular
shape. Masterbatch allows the processor to colour
raw polymer economically during the plastics
manufacturing process.
Packaging Waste System picks the "node" part of Packaging Site Pack Tech
Classification Material value (e.g. Glass, Metal, Paper, Plastic,
Other, Wood)
In alternative, User picks the "node" part of
Packaging Material value (e.g. Glass, Metal,
Paper, Plastic, Other, Wood)
Pharmacopoeia(s) Directions for the features of packaging material(s) Site Pack Tech

44
 used to manufacture the primary containers of
medecine(s), and published by the authority of a
government or a medical or pharmaceutical
society: select one or more
Grammage (g/sqm) Material basic weight (grams) in a given square Site Pack Tech
meter area
Material Thickness Thickness of the material used in packaging Site Pack Tech
components
Backing material(Liner) Coated webbing material to hold selfadhesive Site Pack Tech
label in place
Coating Material Substance used to externally coat the packaging Site Pack Tech
item
Additives Chemicals added to the Packaging Material as Site Pack Tech
part of the manufacturing process. e.g. To prevent
static electricity, catalyst to form the material
Recycled Content (%) Percentage of recycled content in packaging item Site Pack Tech
Material Manufacturer Name Name of manufacturer who provides packaging Site Pack Tech
material (Cardboard for Carton; Thin Paper for
Leaflet; Adhesive Material for Label) to Print
Supplier
Supplier Name Name of the Supplier Site Pack Tech
ECT(kN/m) ECT(kN/m) Site Pack Tech
PET/ Puncture Energy Test(J) PET/ Puncture Energy Test(J) Site Pack Tech
Bursting Strength(kPa) Bursting Strength(kPa) Site Pack Tech
Board Name Board Name Site Pack Tech
Board Grade Board Grade Site Pack Tech
Paper (type and grammage) Paper (type and grammage) Site Pack Tech
Flute (type and grammage) Flute (type and grammage) Site Pack Tech

Appendix 3 – GSK GLAMS System instructions

Name Document Number

GSK GLAMS Basic Navigation System Instruction VQD-WI-051388
Initiating Changes in GSK GLAMS System Instruction VQD-WI-051389
Performing Routing task in GSK GLAMS System Instruction VQD-WI-051390
Performing Review tasks in GSK GLAMS System Instruction VQD-WI-051391
Performing Approval tasks in GSK GLAMS System Instruction VQD-WI-055944
Artwork and Packaging Studio Tasks in GSK GLAMS System Instruction VQD-WI-051392
CMO Personnel progressing changes in GSK GLAMS System Instruction VQD-WI-051393
GSK GLAMS Tracker and Library System Instruction VQD-WI-051395
How to use Proofing tool integrated in GSK GLAMS VQD-WI-051528
How to use Text and Graphic comparison tools integrated in GSK GLAMS VQD-WI-051530

Appendix 4 – How to Cancel a Change

45
Change Initiator can cancel Change at Initiate Data/SKU Change and Define and Update impacted
items/SKU

After those steps, cancellation is possible at any time by Artwork Coordinator/Data Change Coordinator via
Data/SKU Change Tracker.

A Comment must always be sent by who is requesting the cancellation and agreement between LOC and
CMO/Site must be reached before proceeding with the cancellation.

Important Notes:

 When a change is cancelled, any new item and/or any item revision linked to the Change is automatically
cancelled.

 Regarding associated SKUs:

o if they’re new (i.e.: created within the change) they will be cancelled.

o If instead the affected SKUs are existing SKU, any field (i.e.: Secondary Site Item code and Risk
Print) that was updated during the Change must be reinstated to the original value.
It is Artwork Coordinator/Data Change Coordinator responsibility to coordinate and monitor the
activity to reinstate the SKU original attributes before cancelling the Change.

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