Batch Disposition

BATCH DISPOSITION
BATCH DISPOSITION REGULATION
Jakarta 14 DECEMBER 2017
Speaker:
MIMI VIRLANY SYAHPUTRI, M.Sc., S.si., APT
BATCH DISPOSITION
Definition
• Batch disposition = product disposition = lot disposition
• The documented control, status and/or usage for a Product. Examples

include, without limitation, release, rejection, quarantine, hold, release
for packaging, returns, destruction.
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BATCH DISPOSITION
Definition
Applied to :
 Drug Products including Validation and demonstration Batches.
 Active Pharmaceutical Ingredients (API) including validation and demonstration
batches
 Raw Materials (RM);
 API Starting Materials;
 Intermediates;
 In-Process Materials;
 Medical Devices;
 Packaging Materials; and
 Other Materials.

BATCH DISPOSITION
Responsibility
• WHO : Authorized Person

The person recognized by the national regulatory authority as having the
responsibility for ensuring that each batch of finished product has been
manufactured, tested and approved for release in compliance with the
laws and regulations in force in that country.
• EU : Quality Person
Responsible person for batch certification and release required at site is a
basic concept of the European Pharmaceutical legislation, providing the
competent national authorities a perfect recourse within a short timeframe
in case of any issue with a batch certified and released by a particular QP

BATCH DISPOSITION
Responsibility
• US FDA : Quality Unit

A group organized within an organization to promote quality in general
practice
• BPOM : Registered/Qualified Pharmacist
Personnel with adequate training and practical experiences which enable
him/her to perform his/her function professionally. The head of Quality
Management (Quality Assurance) should be given full authority and
responsibility in all quality system /assurance duties, including:

BATCH DISPOSITION
Important Aspect
• Accordance to registered specification/parameter

• Consider following aspect :
• Safety
• Efficacy
• Purity
• Identity
• Quality
• GMP/Compliance

BATCH DISPOSITION
Types
GMP Disposition
- Release from Manufacturing Site to Distribution (Technical Disposition)
- Toll manufacturing Marketing Authorization (MA) holds by other party)
- Country that required local people to do another step of release
Market Disposition
- Released product to market
- Performed by MA holder
Noted : GMP and Market Disposition can be done together

BATCH DISPOSITION
Documents
GMP Disposition
- Batch Record
- Analytical Testing Record/CoA
- Related form/checklist
- Environmental Monitoring Result
- Certificate of Conformance
 Manufactured as per GMP
 Any occurrence/deviation has been investigated and assessed
Market Disposition
- Certificate of Conformance

BATCH DISPOSITION
Types of Disposition
The Product Disposition shall be documented, signed (written or electronic), and

dated by the Quality Team representative making the disposition decision either :
• Approved,
• Quarantine,
• Quarantine-Hold,
• Acceptable for Rework/Reclaim, and
• Rejected.
Document the actual quantity of materials being assigned the disposition

BATCH DISPOSITION
Additional Aspect
Quarantined-Hold, Acceptable for Rework/Reclaim or Rejected)

 To be verified to have been segregated from the portion of the batch or lot that is to
be approved prior to the approval of the rest of the batch or lot.
For Prospective Validation,

 validation reports must be approved prior to product release and distribution of
validation batches in accordance with the established site validation requirements.
For Concurrent Validation,

 Preliminary validation report of each batch must be approved prior to product
release and distribution of validation batch in accordance with the established site
validation requirements.
For Contract Manufacturing

Specify the requirements for approval of products produced by the contract vendor..

BATCH DISPOSITION
General Manufacturing Process
Dispensing
Material Sampling and Filling and Sampling and Batch Final
and Intermediate
Received Testing Packing Testing Status
Compounding
Disposition Disposition Final

Disposition

BATCH DISPOSITION
Pre-requisite System
System for assigning a disposition to • Standard Operating Procedures (SOP)

materials in accordance to regulatory :
• Process Validation
• Material/Process Control Documents
• Out of Specification and Deviation
• Specifications, Management
• Certificate of Analysis (COA), • Complaint and Market Action
• Batch Records, • Stability Management
• Device History Record (DHR) • Reprocess and Reworking
• Certificate of Compliance. • Line Clearance
• Material status indication. • IPC
• Retained Sample
• Supplier Management
• Change Management
• Packaging Development

BATCH DISPOSITION
GxP – Pharmaceutical Quality System – Batch Disposition
HA Law
and
Regulation
GxP
PQS
Batch
Disposition

BATCH DISPOSITION
• Batch disposition = confirmation activities not quality testing activities
• Quality must be built from beginning, not testing at the end
• More robust GMP and PQS System = More robust in Batch Disposition Process =
less chance of having bad product in the market GMP
PQS
Batch
Disposition

BATCH DISPOSITION
• Less robust GMP and PQS System = Vunerable in Batch Disposition Process =
Micro Manage = High chance of having bad product in the market
Batch
Dispostion
PQS
GMP
System

RAW/PACKAGING MATERIAL DISPOSITION
Prerequisite System (not limited to)
• Procedure
GMP • Personnel
• Culture
Supplier • Supplier Management
ManagementPQS Change •
•
Material Management
OOS & Deviation
Management
Control
Lot • Sampling
• Testing
Disposition • Disposition

INTERMEDIATE DISPOSITION
• Procedure
GMP • Personnel
• Culture
Supplier • Line Clearance & EM
ManagementPQS Change •
•
IPC
OOS & Deviation
Management
Control
Lot • Sampling
• Testing
Disposition • Disposition

FINISH PRODUCT DISPOSITION
•Procedure
GMP •Personnel
•Culture
•Change Management
Supplier •Line Clearance & EM
ManagementPQS Change •Record Management

•OOS & Deviation Management
•Material Management
Control
Lot •Process Validation
•Sampling
•Testing
Disposition •Disposition

BATCH DISPOSITION
Key Principles
• Confirmation activities
• Sampling and testing based on sampling approach with destructive testing
• IPC
• Process Validation
• Holistic approach more sustainable than micro manage
• Keep adding checking and sorting step at the end of process are not always best solution

Connecting Pharmaceutical Knowledge ispe.org
Connecting Pharmaceutical Knowledge ispe.org

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BATCH DISPOSITION

BATCH DISPOSITION REGULATION

Jakarta 14 DECEMBER 2017

• Batch disposition = product disposition = lot disposition

• The documented control, status and/or usage for a Product. Examples

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• WHO : Authorized Person

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• US FDA : Quality Unit

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• Accordance to registered specification/parameter

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Noted : GMP and Market Disposition can be done together

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The Product Disposition shall be documented, signed (written or electronic), and

Document the actual quantity of materials being assigned the disposition

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Quarantined-Hold, Acceptable for Rework/Reclaim or Rejected)

For Prospective Validation,

For Concurrent Validation,

For Contract Manufacturing

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Disposition Disposition Final

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System for assigning a disposition to • Standard Operating Procedures (SOP)

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Connecting Pharmaceutical Knowledge ispe.org 13

• Quality must be built from beginning, not testing at the end

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Connecting Pharmaceutical Knowledge ispe.org 15

Connecting Pharmaceutical Knowledge ispe.org 16

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ManagementPQS Change •Record Management

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• Holistic approach more sustainable than micro manage

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