AUROBINDO PHARMA LIMITED, UNIT – VIII Page

STANDARD OPERATING PROCEDURE 1 of 9

Preparation, Review, Approval, Distribution SOP No. QA001
Topic and Retrieval of Standard Operating
Procedure. Version No. 10
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 03/02/2003 To incorporate the Corporate Quality Guidelines.
 Revised due to the merger of Ranit Pharma with Aurobindo Pharma.
02 28/05/2003
 Annexure – II modified.
 One original (master) copy shall be prepared instead of three.
03 01/01/2005
 Annexure – II modified.
04 30/12/2006 SOP is reviewed.
 Change in company logo.
 To define separate numbering system for ERP SOP’s.
05 01/08/2007
 To define separate numbering system for Type – I and Type – II
Cleaning SOP’s.
06 14/09/2008 Revise the procedure to define the effective date of documents.
SOP format and index (Annexure –I & III) revised due to incorporation of
07 14/07/2009 designation column in footer for prepared, checked, and approved persons
and procedure revised for better clarity.
08 14/07/2011 Reviewed due to completion of review period.
 Documents reviewed stamping procedure has been incorporated and
09 17/11/2011 procedure modified.
 Annexure-IV has been incorporated.
Revised due to change in Safety & Environment department name as
10 Environment, Health & Safety and department code as EHS instead of
SE as a harmonization policy.

Prepared By Checked By Approved By

Name T. Satish Kumar P.J.R. Varma T. Venkateswara Rao G.N.A. Srinivasa Rao
Designation Executive – QA D.G.M. – MF Dy.Manager – QA A.G.M. - QA
Signature
Date 15/01/2014 15/01/2014 15/01/2014 15/01/2014
Format No. : QA001–F01–03
 AUROBINDO PHARMA LIMITED, UNIT – VIII Page
STANDARD OPERATING PROCEDURE 2 of 9
Preparation, Review, Approval, Distribution SOP No. QA001
Topic and Retrieval of Standard Operating
Procedure. Version No. 10
Department Quality Assurance Effective Date
Area All Departments Review Date

1.0 PURPOSE
1.1 To lay down a procedure for the preparation, review, approval, distribution and retrieval
of Standard Operating Procedures (SOPs).
2.0 SCOPE
2.1 This procedure is applicable for the preparation of SOPs of all the departments
(Manufacturing, Quality Control, Quality Assurance, Warehouse, Environment,
Health & Safety, Engineering & Utility, Purchase, Electronic Data Processing (EDP)
and Human Resource).
3.0 RESPONSIBILITY
3.1 Concerned departments for preparation and checking.
3.2 QA department for checking and approval.
4.0 ACCOUNTABILITY
4.1 Head – Quality Assurance.
5.0 PROCEDURE
5.1 Preparation of Standard Operating Procedure :
5.1.1 Standard operating procedure shall be prepared after approval of change
control initiation form by quality assurance department.
5.1.2 The Concerned department person who is in-charge of the operation shall
prepare the SOP as per the specimen format given in Annexure – I.
5.1.3 All the characters in SOP Header, Footer and text matter shall be typed in
“Times New Roman” with font size of “12”, except Format Number
mentioned in footer shall be typed in “Times New Roman” with font
size of “8”.
5.1.4 SOP Format
5.1.4.1 The SOP format consists of the following information in the respective cells
of the specimen format given in Annexure – I. Cell Numbers (01 to 11) shall not
appear in the SOPs. They are given only for explanation.
Cell
Information Text Type
Number
01 Company Logo ---
02 Company Name with Unit Code Bold & Upper Case
03 Subject Matter Bold & Upper Case

Prepared By Checked By Approved By

Name T. Satish Kumar P.J.R. Varma T. Venkateswara Rao G.N.A. Srinivasa Rao
Designation Executive – QA D.G.M. – MF Dy.Manager – QA A.G.M. - QA
Signature
Date 15/01/2014 15/01/2014 15/01/2014 15/01/2014
Format No. : QA001–F01–03
 AUROBINDO PHARMA LIMITED, UNIT – VIII Page
STANDARD OPERATING PROCEDURE 3 of 9
Preparation, Review, Approval, Distribution SOP No. QA001
Topic and Retrieval of Standard Operating
Procedure. Version No. 10
Department Quality Assurance Effective Date
Area All Departments Review Date

Cell
Information Text Type
Number
04 Topic of the SOP Title case
05 Name of the Originating department Title Case
06 Area of Application Title Case
Page X of Y [X is the current page number Sentence Case &
07
and Y is the total number of pages] Alphanumerical
Upper Case &
08 SOP Number as per section 5.1.12
Alphanumerical
09 Version number as per section 5.1.14 Numericals
10 Date of Implementation Keep blank
Review date of SOP
11 Keep blank
(2 years from the effective date)

5.1.5 The Content (text matter) of the SOP :

5.1.5.1 All subheadings of the SOP shall be taken in bold upper case letters.
The subheadings are listed section-wise.
5.1.6 Revision Summary :
5.1.6.1 It details the history of SOP i.e. the changes undergone since first
issue of the SOP in ascending order.
5.1.7 Purpose :
5.1.7.1 It defines the purpose for which the SOP is written. It starts with the
sentence “To lay down a procedure for ………..”.
5.1.8 Scope :
5.1.8.1 It defines the area of application.
5.1.9 Responsibility :
5.1.9.1 Department Head / Deputy directly associated with the
implementation of the SOP and Quality Assurance Department
person who checks the write up.
5.1.10 Accountability :

Prepared By Checked By Approved By

Name T. Satish Kumar P.J.R. Varma T. Venkateswara Rao G.N.A. Srinivasa Rao
Designation Executive – QA D.G.M. – MF Dy.Manager – QA A.G.M. - QA
Signature
Date 15/01/2014 15/01/2014 15/01/2014 15/01/2014
Format No. : QA001–F01–03
 AUROBINDO PHARMA LIMITED, UNIT – VIII Page
STANDARD OPERATING PROCEDURE 4 of 9
Preparation, Review, Approval, Distribution SOP No. QA001
Topic and Retrieval of Standard Operating
Procedure. Version No. 10
Department Quality Assurance Effective Date
Area All Departments Review Date

5.1.10.1 Person / Persons directly associated with the system.

5.1.11 Procedure :
5.1.11.1 Details of the actual work carried out with stepwise operations /
activities.
5.1.12 End of Document :
5.1.12.1 Indicates the end of SOP.
5.1.13 SOP Numbering System for General SOP’s :
5.1.13.1 Each SOP shall have an unique number consisting of five characters of
alphanumeric system as described below.

AA (or) AAA NNN

3 numerals for SOP serial number, department

wise starting from ‘001’
2 (or) 3 alphabets of Department code
5.1.14 Department Code :
5.1.14.1 The department code shall be considered as per the code
mentioned in the following table, but it is not limited to :
Department
S. No. Department Name
Code
01 Quality Assurance QA
02 Quality Control QC
03 Manufacturing MF
04 Warehouse – API WA
05 Engineering & Utility EU
06 Human Resource HR
07 Environment, Health & Safety EHS
08 Process Development Laboratory DL
09 Electronic Data Process (EDP) IT
10 Purchase Department PU

Prepared By Checked By Approved By

Name T. Satish Kumar P.J.R. Varma T. Venkateswara Rao G.N.A. Srinivasa Rao
Designation Executive – QA D.G.M. – MF Dy.Manager – QA A.G.M. - QA
Signature
Date 15/01/2014 15/01/2014 15/01/2014 15/01/2014
Format No. : QA001–F01–03
 AUROBINDO PHARMA LIMITED, UNIT – VIII Page
STANDARD OPERATING PROCEDURE 5 of 9
Preparation, Review, Approval, Distribution SOP No. QA001
Topic and Retrieval of Standard Operating
Procedure. Version No. 10
Department Quality Assurance Effective Date
Area All Departments Review Date

Department
S. No. Department Name
Code
11 Marketing Department MK

5.1.15 SOP Numbering System for Enterprises Resource Planning (ERP) SOP’s :
5.1.15.1 Each SOP shall have an unique number consisting of eight characters of
alphanumeric system as described below.

AA (or) AAA ERP NNN

3 numerals for SOP serial number,

department wise starting from ‘001’
Code of Enterprises Resource Planning
2 (or) 3 alphabets of Department
code as per step no. 5.1.14

5.1.16 SOP Numbering System for Cleaning (Type – I / Type – II) SOP’s :
5.1.16.1 Each cleaning SOP shall have an unique number consisting of five characters
of alphanumeric system as described below.

CS NNN

3 numerals for SOP serial number,

starting from ‘001’
Type of SOP
(i.e. ‘CS’ for Cleaning SOP)

5.1.17 SOP Numbering System for Specimen Label SOP’s :

5.1.17.1 Each SOP shall have an unique number of alphanumeric system as
described below.

SL WA NNN
Numeric SOP serial number,
starting from 01, 02, 03 ….. so on
Prepared By Checked By Approved By
Name T. Satish Kumar P.J.R. Varma T. Venkateswara Rao G.N.A. Srinivasa Rao
Designation Executive – QA D.G.M. – MF Dy.Manager – QA A.G.M. - QA
Signature
Date 15/01/2014 15/01/2014 15/01/2014 15/01/2014
Format No. : QA001–F01–03
 AUROBINDO PHARMA LIMITED, UNIT – VIII Page
STANDARD OPERATING PROCEDURE 6 of 9
Preparation, Review, Approval, Distribution SOP No. QA001
Topic and Retrieval of Standard Operating
Procedure. Version No. 10
Department Quality Assurance Effective Date
Area All Departments Review Date

2 alphabets of Warehouse Dept.

code as per step no. 5.1.14
Type of SOP
(i.e. ‘SL’ for Specimen Label SOP)
5.1.18 Version Number :
5.1.18.1 The version number shall be as given below.

S. No. Version Number

01 First issue 00
02 Second issue 01
03 Third issue and so on….. 02…..so on
Example-1 : The first SOP number of Quality Assurance department shall be
QA001 which indicates that this is the first SOP of Quality
Assurance Department.
Example-2 : The cleaning SOP number of Stainless Steel Reactor present in
Production Block – A shall be “CSA001”, which indicates that this
is the first Cleaning SOP of Production Block – A.
5.1.19 The SOP approval shall be as described below :
5.1.19.1 QA or Concerned department person shall take one original set of
print on A4 copier size white paper and it shall be signed as
described below.
5.1.19.2 The name and designation of person who prepares the SOP shall
be given. He shall sign in the “PREPARED BY” column along
with date.
5.1.19.3 The Concerned department Head or his Deputy’s name and
designation shall appear in the one part of “CHECKED BY”
column. After checking the SOP, he shall sign along with date. In
case of system SOP’s (QA SOP’s), they shall be checked by Head
– MF or his deputy. He shall sign in this part along with date.
5.1.19.4 The name and designation of QA person who shall check appear in
the another part of “CHECKED BY” column. After checking the
SOP, he shall sign along with date.

Prepared By Checked By Approved By

Name T. Satish Kumar P.J.R. Varma T. Venkateswara Rao G.N.A. Srinivasa Rao
Designation Executive – QA D.G.M. – MF Dy.Manager – QA A.G.M. - QA
Signature
Date 15/01/2014 15/01/2014 15/01/2014 15/01/2014
Format No. : QA001–F01–03
 AUROBINDO PHARMA LIMITED, UNIT – VIII Page
STANDARD OPERATING PROCEDURE 7 of 9
Preparation, Review, Approval, Distribution SOP No. QA001
Topic and Retrieval of Standard Operating
Procedure. Version No. 10
Department Quality Assurance Effective Date
Area All Departments Review Date

5.1.19.5 Head – QA or his nominee shall finally approve the SOP. He shall
sign in the “APPROVED BY” column along with date.
5.1.19.6 Ensure that the date shall be written with Day, Month and Year.
5.1.20 Quality assurance shall handover the approved document to training
coordinator for training.
5.1.21 Training coordinator shall coordinate with concerned department head for
training arrangements.
5.1.22 Based on the approved document, training shall be given to all concerned
employees by concerned department.
5.1.23 Head of concerned department shall handover all the training documents
along with approved document to training coordinator.
5.1.24 After receiving the training documents, training coordinator shall handover
the approved document along with one set Xerox copy of training document
to Quality assurance.
5.1.25 Quality assurance department shall close the change control. Based on the
closing of change control the effective date and review dates shall be stamped
with blue ink in relevant columns of document.
5.1.26 Distribution of SOPs :
5.1.26.1 SOPs shall be distributed as described below.
5.1.26.2 Original Copy shall be stamped as “MASTER COPY” in red ink
in upper left corner on all pages and shall be archived in QA
department as Documentation Cell Copy.
5.1.26.3 Based on the area of application, required number of user copies
shall be photocopied from the “Master Copy” and stamped as
“CONTROLLED COPY” in blue ink on bottom corner towards
right hand side on all pages with an initial of QA representative
along with the copy number and date.
5.1.26.4 Two user copies to concerned department and one user copy each
to all connected departments shall be issued.
5.1.26.5 QA person shall record the distribution details in Document Issue,
Retrieval & Destruction Record for each SOP as given in

Prepared By Checked By Approved By

Name T. Satish Kumar P.J.R. Varma T. Venkateswara Rao G.N.A. Srinivasa Rao
Designation Executive – QA D.G.M. – MF Dy.Manager – QA A.G.M. - QA
Signature
Date 15/01/2014 15/01/2014 15/01/2014 15/01/2014
Format No. : QA001–F01–03
 AUROBINDO PHARMA LIMITED, UNIT – VIII Page
STANDARD OPERATING PROCEDURE 8 of 9
Preparation, Review, Approval, Distribution SOP No. QA001
Topic and Retrieval of Standard Operating
Procedure. Version No. 10
Department Quality Assurance Effective Date
Area All Departments Review Date

Annexure – II. This record shall be attached to the

Documentation Cell SOP.
5.1.26.6 If additional copies are required, concerned department shall give
request (I.O.C.) to Quality Assurance department. QA shall issue
the additional copies to concerned department as per 5.1.26.3 and
details shall be recorded in corresponding Document Issue,
Retrieval & Destruction Record.
5.1.26.7 When SOP has to be distributed outside the premises and out of
the company’s control, photocopy of the “Master Copy” of that
particular SOP shall be taken and stamped as
“UNCONTROLLED COPY NOT FOR OPERATIONAL
USE” in red ink in bottom of the document.
5.1.26.8 When SOP has to be distributed to Regulatory Affairs department
for regulatory filing, photocopy of the “Master Copy” of that
particular SOP shall be taken and issued to Regulatory Affairs
department.
5.1.26.9 An index with current version number of all SOPs of individual
departments shall be prepared as per the format given in
Annexure–III. The current index shall be filed with the
Documentation Cell SOPs and User Department SOPs.
5.1.27 Revision of SOPs :
5.1.27.1 SOP shall be reviewed and revised every 2 years or as and when it
needs revision (through change control).
5.1.27.2 In case of discontinuation of SOP, the particular SOP number shall
not be assigned to any other SOP.
5.1.27.3 In the month of review period Standard Operating Procedures shall
be reviewed. If no changes observed in the existing standard
operating procedure, the documents shall be stamped as
“REVIEWED FOUND SATISFACTORY” on the first page left side. The
format of stamp is given as Annexure IV.
If there is no change in the SOP after 6 years for approval new
print shall be taken and issued to concerned departments. Existing
SOP shall be obsoleted.

Prepared By Checked By Approved By

Name T. Satish Kumar P.J.R. Varma T. Venkateswara Rao G.N.A. Srinivasa Rao
Designation Executive – QA D.G.M. – MF Dy.Manager – QA A.G.M. - QA
Signature
Date 15/01/2014 15/01/2014 15/01/2014 15/01/2014
Format No. : QA001–F01–03
 AUROBINDO PHARMA LIMITED, UNIT – VIII Page
STANDARD OPERATING PROCEDURE 9 of 9
Preparation, Review, Approval, Distribution SOP No. QA001
Topic and Retrieval of Standard Operating
Procedure. Version No. 10
Department Quality Assurance Effective Date
Area All Departments Review Date

5.1.27.4 If any change required in Annexure, the particular Annexure shall

be revised through change control and the old Annexure shall be
replaced with revised Annexure.
5.1.27.5 QA person shall ensure the retrieval of distributed copies except
uncontrolled copies, prior to issue of revised SOPs.
5.1.27.6 QA person shall ensure the retrieval of all the copies and destroy,
except “Documentation Cell Copy”.
5.1.27.7 “Documentation Cell Copy” of previous version shall be stamped
as “OBSOLETE COPY FOR REFERENCE ONLY” in red
colour over the printed matter on all pages with an initial of QA
representative along with date and archived in QA department in a
separate file.

END OF DOCUMENT

Prepared By Checked By Approved By

Name T. Satish Kumar P.J.R. Varma T. Venkateswara Rao G.N.A. Srinivasa Rao
Designation Executive – QA D.G.M. – MF Dy.Manager – QA A.G.M. - QA
Signature
Date 15/01/2014 15/01/2014 15/01/2014 15/01/2014
Format No. : QA001–F01–03