AUROBINDO PHARMA LIMITED, UNIT – VIII Page

STANDARD OPERATING PROCEDURE 1 of 7

SOP No. QA003

Topic Document Control.
Version No. 15
Department Quality Assurance Effective Date
Area All Departments Review Date

REVISION SUMMARY
Version Effective Date Reason for Revision
Number
00 25/10/2001 First Issue.
01 01/01/2003 For better clarity
02 20/02/2003 To incorporate the Corporate Quality Guidelines
03 28/05/2003 Revised due to the merger of Ranit Pharma with Aurobindo Pharma.
1. Methodology for Issue and control of Raw Data Worksheets to
Quality Control department is incorporated, accordingly new
04 01/01/2004 format also included.
2. Formats included for “Issue of Uncontrolled Documents” as
Annexure – V and “Master List of Documents” as Annexure – VI.
1. To revise the methodology for issue of Raw Data Worksheets to
Quality Control department.
05 25/10/2004
2. To revise the document destruction procedure.
3. To change the Annexure – IV accordingly.
06 01/01/2005 One original (master) copy shall be prepared instead of three.
07 30/12/2006 SOP is reviewed.
08 01/08/2007 Due to change in Company Logo.
To split the instrument section worksheet into location wise and change
09 19/04/2008
the numbering system of worksheet accordingly.
10 19/04/2010 Revised due to revision of SOP format and review period completed.
1. To include EMS Manual in list of documents.
11 06/01/2011 2. In 5.9, Manager – QA / QC is changed as Head-QA.
3. Annexure-VI revised inclusion of survey no.10.
12 07/12/2011 To incorporate issue procedure for Analytical raw data booklets.
13 13/05/2013 To revise the issue procedure of formats.
14 26/06/2013 To revise the issue procedure of formats.
15 Procedure elaborated at step No.:5.6.6 and 5.6.7.

Prepared By Checked By Approved By

Name P. Ankamma Rao M.A.V.G.K. Murthy P.J.R. Varma G. Srinivasulu
Designation Executive - QA Asst. Manager - QA DGM - Operations Dy. Manager - QA
Signature
Date 16/08/2014 16/08/2014 16/08/2014 16/08/2014
Format No. : QA001–F01–03
 AUROBINDO PHARMA LIMITED, UNIT – VIII Page
STANDARD OPERATING PROCEDURE 2 of 7

SOP No. QA003

Topic Document Control.
Version No. 15
Department Quality Assurance Effective Date
Area All Departments Review Date

1.0 PURPOSE
1.1 To lay down a procedure for the control of documents.
2.0 SCOPE
2.1 This SOP is applicable for control of documents, approved by Quality Assurance
Department (QAD).
3.0 RESPONSIBILITY
3.1 Document Controller.
4.0 ACCOUNTABILITY
4.1 Head – Quality Assurance.
5.0 PROCEDURE
5.1 Objective of Document Control :
5.1.1 To execute the approved and current written procedures & policies.
5.1.2 To record the raw data and logging of operation in approved formats.
5.1.3 To control the usage of raw data formats through controlled issue.
5.1.4 To control the storage, revision, distribution and destruction of documents.
5.2 List of Documents :
5.2.1 Written Procedures / Policies
 Standard Operating Procedures (SOP’s)
 Specifications (SP’s)
 Standard Testing Procedures (STP’s)
 General Testing Procedures (GTP’s)
 Master Production and Control Records (MPCR’s)
 Batch Production and Control Records (BPCR’s)
 Validation Master Plan (VMP)
 Validation Protocols
 Site Master File (SMF)
 Quality Manual
 EMS Manual
 Stability Protocols …. etc.
5.2.2 Formats to record the observations during respective operation.
5.2.3 Drawings
Prepared By Checked By Approved By
Name P. Ankamma Rao M.A.V.G.K. Murthy P.J.R. Varma G. Srinivasulu
Designation Executive - QA Asst. Manager - QA DGM - Operations Dy. Manager - QA
Signature
Date 16/08/2014 16/08/2014 16/08/2014 16/08/2014
Format No. : QA001–F01–03
 AUROBINDO PHARMA LIMITED, UNIT – VIII Page
STANDARD OPERATING PROCEDURE 3 of 7

SOP No. QA003

Topic Document Control.
Version No. 15
Department Quality Assurance Effective Date
Area All Departments Review Date

5.3 Documents shall be prepared and approved as per their respective SOP’s.
5.4 Original Copy (Master Copy) of document shall be archived in Documentation Cell.
5.5 Distribution of Written Procedures / Documents :
5.5.1 QA shall distribute the written procedures / documents to the concerned
department.
5.5.2 Photocopy shall be taken from the respective “Master Copy”. All
photocopies shall be stamped as “Controlled Copy” and distributed to user
department as per the current version of SOP No. : QA001.
5.5.3 QA shall maintain the distribution record as per Annexure – II, current
version of SOP No. : QA001.
5.6 Distribution of Raw Data Worksheets to Quality Control department :
5.6.1 Based on the request from Manufacturing department, QA person shall
arrange the photocopies of BPCR’s and RAR’s. QA person shall check the
Master List of SP, STP & Worksheets for that product to issue the relevant
worksheets / booklets after taking photocopy from respective “Controlled
Copy”.
5.6.2 QA person shall put the work sheets in analytical data worksheet folder,
staples the folder and put the stamp in section column as Chemical / HPLC /
GC / Other Instruments / Microbiology / Calibration / Working standard /
Stability.
5.6.3 QA person shall fill the columns relating to QA on the top page of the folder,
puts QA stamp, sign. & date on the top page only.
5.6.4 QA person shall give book number to each worksheet booklet as given below.

PD X / AAA - 0001 / YY

Where
PD is Product Code as per current version of SOP No. : QA023
X is Stage No.
AAA is Work sheet type
Chemical Lab QWC
HPLC QLC
GC QGC

Prepared By Checked By Approved By

Name P. Ankamma Rao M.A.V.G.K. Murthy P.J.R. Varma G. Srinivasulu
Designation Executive - QA Asst. Manager - QA DGM - Operations Dy. Manager - QA
Signature
Date 16/08/2014 16/08/2014 16/08/2014 16/08/2014
Format No. : QA001–F01–03
 AUROBINDO PHARMA LIMITED, UNIT – VIII Page
STANDARD OPERATING PROCEDURE 4 of 7

SOP No. QA003

Topic Document Control.
Version No. 15
Department Quality Assurance Effective Date
Area All Departments Review Date

Other Tests QOT

Microbiology Lab QMB
0001 is Sequential No. of particular stage of the product.
YY is Last two digits of the Calendar Year
5.6.5 QA shall record the issue details in the format as given in Annexure – IV and
distributes the worksheet booklets to Quality Control department.
5.6.6 Manufacturing department shall handover the executed BPCR to QA along
with RAR after completion of Manufacturing process.
5.6.7 Upon verification of executed BPCR for correctness, QA Personnel shall
handover the RAR to QC analyst for necessary action.
5.6.8 For Raw materials, Stability samples, R&D samples and other Vendor
samples, QC shall raise the “Format Issue Request” as given in Annexure – I.
5.6.9 QA person shall arrange the corresponding worksheet booklets.
5.6.10 If issued worksheet is damaged, QC In-charge shall raise the “Additional
Worksheet Issue Request” as given in Annexure – VII along with
justification. After approval by Head – QA, QA person shall arrange
additional worksheet on same Batch No. and file the damaged worksheet in
separate file.
5.7 Conversion of Formats into Bound Books / Booklets / Pads.
5.7.1 The Document Controller shall take photocopy of the “Documentation Cell
Copy” of format and stamp “Uncontrolled Copy Not For Operational Use”
Red ink in bottom of the document and it shall be given for printing through
Purchase Department as bound book or booklets or pads based on
requirement.
5.7.2 The final printed bound book / booklet / pads shall be compared with
“Documentation Cell Copy” on receipt from the printer.
5.7.3 The total number of books received from the printer shall be taken into stock
after approved by Quality Assurance department.
5.7.4 The first page of bound book / booklet shall contain the issue in format as
given in Annexure – II.
5.8 Issue of Formats :

Prepared By Checked By Approved By

Name P. Ankamma Rao M.A.V.G.K. Murthy P.J.R. Varma G. Srinivasulu
Designation Executive - QA Asst. Manager - QA DGM - Operations Dy. Manager - QA
Signature
Date 16/08/2014 16/08/2014 16/08/2014 16/08/2014
Format No. : QA001–F01–03
 AUROBINDO PHARMA LIMITED, UNIT – VIII Page
STANDARD OPERATING PROCEDURE 5 of 7

SOP No. QA003

Topic Document Control.
Version No. 15
Department Quality Assurance Effective Date
Area All Departments Review Date

5.8.1 Formats for recording shall be issued by QA on request from the respective
departments as per the format given in Annexure – I as loose sheets or in the
form of bound book.
5.8.2 Required number of loose formats shall be photocopied by using respective
“Documentation Cell Copy”.
5.8.3 Format issue shall be recorded department-wise with unique issue reference
number. The Numbering System shall be as given below;
AA / NN / NNN

Serial Number starting from ‘001’

Slash
Last 2 digits of Calendar Year
Slash
Department Code (Refer SOP No.: QA001)

5.8.4 Loose formats shall be stamped with “ISSUED BY QA” stamp with initial of
QA person along with date and then issued.
5.8.5 BPCR, log books and work sheets shall be stamped with “ISSUED BY QA”
stamp with sign. & date of QA person on top page only.
5.8.6 Before issue of format bound book, QA shall ensure that all pages are
matching with approved format as per “Documentation Cell Copy”.
5.8.7 All pages of format bound book shall have a serial number.
5.8.8 QA person shall write the issue details in the front page of book as per the
format given in Annexure – II.
5.8.9 QA shall record the format issue details in a register, department wise as
given in Annexure – III.

Prepared By Checked By Approved By

Name P. Ankamma Rao M.A.V.G.K. Murthy P.J.R. Varma G. Srinivasulu
Designation Executive - QA Asst. Manager - QA DGM - Operations Dy. Manager - QA
Signature
Date 16/08/2014 16/08/2014 16/08/2014 16/08/2014
Format No. : QA001–F01–03
 AUROBINDO PHARMA LIMITED, UNIT – VIII Page
STANDARD OPERATING PROCEDURE 6 of 7

SOP No. QA003

Topic Document Control.
Version No. 15
Department Quality Assurance Effective Date
Area All Departments Review Date

5.9 Issue of Documents to outside agencies :

5.9.1 As per the customer request, QA person shall arrange the photocopy of
concerned master document on advice of the Head – QA and shall stamp as
“Uncontrolled Copy, Not For Operational Use”.
5.9.2 QA shall record the issue details in the format as given in Annexure – V.

5.10 Archival of Documents :

5.10.1 QA department shall have a Document Storage facility to archive the
following documents :
5.10.1.1 Documentation Cell Copy of all documents mentioned in section 5.2
5.10.1.2 Executed BPCRs
5.10.1.3 Quality Control Test Records
5.10.1.4 Validation Protocols and Reports
5.10.1.5 Stability Study Records (Protocols / Schedules / Reports)
5.10.1.6 Trend Reports & Annual Product Reviews
5.10.1.7 All Equipment Log Books
5.10.1.8 Obsolete Documents
5.10.2 Warehouse shall have a separate document storage facility to archive their
executed documents.
5.11 Review and Revision of Documents :
5.11.1 Documents shall be reviewed as per their prescribed review period or revised
as and when it is needed. Document revision shall be effected through Change
Control SOP (SOP No. : QA007 of current version).
5.11.2 QA shall ensure the control of revision as given below :
5.11.2.1 All previous controlled documents shall be retrieved from their
place of operation.

Prepared By Checked By Approved By

Name P. Ankamma Rao M.A.V.G.K. Murthy P.J.R. Varma G. Srinivasulu
Designation Executive - QA Asst. Manager - QA DGM - Operations Dy. Manager - QA
Signature
Date 16/08/2014 16/08/2014 16/08/2014 16/08/2014
Format No. : QA001–F01–03
 AUROBINDO PHARMA LIMITED, UNIT – VIII Page
STANDARD OPERATING PROCEDURE 7 of 7

SOP No. QA003

Topic Document Control.
Version No. 15
Department Quality Assurance Effective Date
Area All Departments Review Date

5.11.2.2 Original previous version of document available with

Documentation Cell shall be stamped as “Obsolete Copy For
Reference Only” and filed at Documentation Cell.
5.11.2.3 All other controlled copies shall be destroyed.
5.11.2.4 Destruction of documents shall be recorded.
5.11.2.5 New versions shall be kept in place for execution or guidance.
5.12 Destruction of Documents :
5.12.1 Retrieved documents shall be destroyed by shredding or by incineration.
5.12.2 The following documents shall not be destroyed.
5.12.2.1 “Obsolete Copy For Reference Only” and current documents.
5.12.2.2 Executed documents, which are submitted to Regulatory
Authorities.
5.12.2.3 Validation protocols and reports.
5.12.3 Executed documents shall be destroyed after 1 year of product expiry either
by shredding or by incineration.
5.13 Master List of Documents :
5.13.1 Document Controller shall list the approved documents department wise as
per the format given in Annexure – VI.
5.13.2 Responsibility of preparation, review and approval shall be lies with
Document Controller, Asst. Manager / Dy. Manager – QA and Head – QA
respectively.
5.13.3 This file shall be available in Quality Assurance department under the
responsibility of Document Controller.
5.13.4 The Master List shall be updated once in three months or as and when it is
required.

END OF DOCUMENT

Prepared By Checked By Approved By

Name P. Ankamma Rao M.A.V.G.K. Murthy P.J.R. Varma G. Srinivasulu
Designation Executive - QA Asst. Manager - QA DGM - Operations Dy. Manager - QA
Signature
Date 16/08/2014 16/08/2014 16/08/2014 16/08/2014
Format No. : QA001–F01–03