SOLITAIRE PHARMACIA PVT. LTD.

RESTRICTED CIRCULATION
STANDARD OPERATING PROCEDURE AUTHORISED PERSONS ONLY

Title: Document Preparation, Control and Retention SOP. No. : SPL/ SOP/QA/002
Page No. : 1 of 6
Supersedes : New
Revision No. : 00
Prepared By Checked By Reviewed By Approved By Effective Date Review Date
Concerned Dept Concerned Dept QA QA-Head

1. Objective
To define the procedure for the preparation, control, and retention of GMP relevant
documents.

2. Scope
This standard operating procedure (SOP) is applicable for all departments of Solitaire
Pharmacia Pvt. Ltd., Baddi that are concerned with document as defined below-
DOCUMENT-: The word “Document” shall cover standard information, instruction and
records concerning facilities, material, manufacturing process or systems that are
established in Solitaire Pharmacia Pvt. Ltd., Baddi and have good manufacturing practice
(GMP) impact directly or indirectly, for example-:

Information

Site master plan

Drawing

Specification

Instructions

Standard Testing procedure(STP)

Protocols

Records

Batch manufacturing record

Completed forms, etc.

3. Responsibility

All employees of Solitaire Pharmacia Pvt. Ltd., Baddi who create, revise, check and
approve the document are responsible for adhering to the content described in this SOP.

Quality Assurance is responsible for assuring the appropriate control over document such as
distribution, change, retention and destruction of the document.

4. Accountability
Head QA

Format No.SPL/QA/001
 SOLITAIRE PHARMACIA PVT. LTD.
RESTRICTED CIRCULATION
STANDARD OPERATING PROCEDURE AUTHORISED PERSONS ONLY

Title: Document Preparation, Control and Retention SOP. No. : SPL/ SOP/QA/002
Page No. : 2 of 6
Supersedes : New
Revision No. : 00
Prepared By Checked By Reviewed By Approved By Effective Date Review Date
Concerned Dept Concerned Dept QA QA-Head

5. Procedure

5.1 Document Preparation

5.1.1 The documents mentioned in section 2.0, can be written by any trained personnel of the
concerned department.

5.1.2 All the documents have to be prepared or written in general English/Local language (If
applicable)

5.1.3 Once the document is drafted, it is to be reviewed for its applicability, completeness and
correctness by a reviewing authority.

5.1.4 After reviewing and signing, the document shall be handed over to “Quality Assurance
Department” (QA) for approval.

5.1.5 Q.A Head shall review the document for its compliance with cGMP/Regulatory
requirement/In-House quality systems and approve the document.

5.1.6 The approved copy of the document shall be sent to the Head of the concerned
department, /Training coordinator for carrying out the training (if require).

5.1.7 After the completion of the training or other action (if any), QA department will write the
effective date and next review date on the original document. The date will either be printed
on the document or else it would be manually written.

5.2 Document Control

5.2.1 All the document shall be controlled and distributed by the Q.A department.
5.2.2 Master copy of document shall be stamp at the bottom right corners of each page as
“MASTER COPY” in red stamp.
5.2.3 The copies of the document, which are meant for the use, are to be stamped as
“CONTROLLED COPY” in blue. Controlled copy shall not be further photocopied.

5.2.4 The copies of the document, which are meant for reference, only are to be stamped as
“UNCONTROLLED COPY” in red.
5.2.5 New document shall be distributed on current version of format no. SPL/QA/002.
5.2.6 Withdrawal of any document shall be done as per current version of format no.
SPL/QA/005.

Format No.SPL/QA/001
 SOLITAIRE PHARMACIA PVT. LTD.
RESTRICTED CIRCULATION
STANDARD OPERATING PROCEDURE AUTHORISED PERSONS ONLY

Title: Document Preparation, Control and Retention SOP. No. : SPL/ SOP/QA/002
Page No. : 3 of 6
Supersedes : New
Revision No. : 00
Prepared By Checked By Reviewed By Approved By Effective Date Review Date
Concerned Dept Concerned Dept QA QA-Head

5.2.7 Quality assurance shall retrieve the control copy of documents. All retrieved obsolete
controlled document shall be destroyed by Q.A and the obsolete master copies shall be
stamped with OBSOLETE in Red stamp on each page.
5.2.8 In case of revision of document, Quality assurance shall retrieve the superseded documents. All
the retrieved superseded controlled document shall be destroyed by Q.A and the superseded
master copies shall be stamped with SUPERSEEDED in Red stamp on each page.
5.2.9 All the SOPs are control, distributed, retrieve and destructed as per SOP
no.”SPL/SOP/QA/001”
5.2.10 The record shall be maintained by Q.A department for distribution, retrieval and destruction of
document as per format no. SPL/QA/003.
5.2.11 Formats & Logbooks shall be issued as per current version of format no “SPL/QA/008”
(Formats /Logbooks Issuance Record).
5.2.11.1 All formats and logbooks shall be a part of SOP.
5.2.11.2 The master copy of all the formats and logbooks shall be maintained by QA department.
5.2.11.3 The quality assurance department shall issue the control copy of formats and logbooks to all
concern departments as per Format no SPL/QA/008.
5.2.11.4 Using control copy as a reference the concern department may print the formats and logbooks
in the form of books/pads in A4 size paper as per their requirement and will take approval
from QA.
5.2.11.5 Each book / pad shall contain 100 formats or logbooks or as per requirement.
5.2.11.6 The formats and logbooks shall be issued by QA department by maintaining format control
log book as per Format no SPL/QA/008.
5.2.11.7 The log book details shall be stamped on the cover page of the all issued formats and
logbooks books/pads.
5.2.11.8 Note :
In case if the printed formats and logbooks are not available then QA will issue the control
copy of required format and logbook to user department.
5.2.11.9 Photocopy of control copy is not allowed.
5.3 Document Retention
5.3.1 All the documents (process validation reports, production records Qualification
records like DQ, IQ, OQ and PQ, training records distribution records etc.) shall
be retained as per the following table (Table-1)

Table -1
Format No.SPL/QA/001
 SOLITAIRE PHARMACIA PVT. LTD.
RESTRICTED CIRCULATION
STANDARD OPERATING PROCEDURE AUTHORISED PERSONS ONLY

Title: Document Preparation, Control and Retention SOP. No. : SPL/ SOP/QA/002
Page No. : 4 of 6
Supersedes : New
Revision No. : 00
Prepared By Checked By Reviewed By Approved By Effective Date Review Date
Concerned Dept Concerned Dept QA QA-Head

S.
Description of the document Retention Period
No.
1. Equipment History sheets Life Cycle +1 year
2. Calibration Records Life Cycle +1 year
3. Preventive Maintenance Records 5 years
4. Formats & Logbooks 5 years
Warehouse Records:
5. Stock records 5 years
6. Distribution Records 5 years
Validation Reports:
7. Development Reports For ever
8. Technology Transfer documents For ever
Training Records:
9. All Training Records Till employees is with
company +5 year
Supporting systems:
10. Utilities documentation Life Cycle +1 year
Production;
Batch Manufacturing Records Shelf life of Batch +1
11.
year
12. Equipment Cleaning Records 5 years
13. Formats & Logbooks 5 years
Quality Control:
14. Qualification Records (IQ, OQ and PQ) Life Cycle+1year
15. Testing Records (Batch Analytical Report) Shelf life of Batch+1
year
16. Calibration Records 5 years
17. Analytical Method Validation Life Cycle +1 year
18. Formats & Logbooks 5 years
Quality Assurance Records
19. Change Control Records 5 years
20. Deviations Records 5 years
21. OOS Records 5 years
22. Market Complaint Records, Product Recall Records 5 years

Format No.SPL/QA/001
 SOLITAIRE PHARMACIA PVT. LTD.
RESTRICTED CIRCULATION
STANDARD OPERATING PROCEDURE AUTHORISED PERSONS ONLY

Title: Document Preparation, Control and Retention SOP. No. : SPL/ SOP/QA/002
Page No. : 5 of 6
Supersedes : New
Revision No. : 00
Prepared By Checked By Reviewed By Approved By Effective Date Review Date
Concerned Dept Concerned Dept QA QA-Head

23. Vendor Records 5 years

24. Master Formula Records For ever
25. Master-Equipment Cleaning Records Life Cycle +1 year
26. Superseded - Standard Operating Procedure 5 years
27. Superseded - Standard Testing Procedure/ 5 years
28. Specification
All Validation Records Life Cycle +1 year
29. Formats & Logbooks 5 years
30. Report of Internal Audit 5 years
31. External customer Audit 5 years
32. Report of Regulatory Audit For ever
HR Records
33. Medical Checkup Records Till employees is with
company +5year
34. Employees Records (Job Responsibility, Signature Till employees is with
specimen log) company +5 year
Engineering Records:
35. Qualification Records (IQ, OQ and PQ) life cycle + 1 years

5.3.1.1 Note-LC means “Life cycle” of the product where shelf life is included.”Life cycle” means
the process staring with the user requirements, continues through design, qualification,
process validation and maintenance until the status label of “NOT IN USE”.
5.3.2 Document after the retention period should be destroyed either by burning or by shredding.
5.3.3 Documents that shall be destroyed after the retention period is over shall be listed and
permission shall be taken from Head-QA & record maintain per current format
SPL/QA/003.

6. Records/Formats
SPL/QA/008 - Formats /Logbook Issuance Record

7. Annexure
NA

8. Reference

ICH Guideline -Q7

Format No.SPL/QA/001
 SOLITAIRE PHARMACIA PVT. LTD.
RESTRICTED CIRCULATION
STANDARD OPERATING PROCEDURE AUTHORISED PERSONS ONLY

Title: Document Preparation, Control and Retention SOP. No. : SPL/ SOP/QA/002
Page No. : 6 of 6
Supersedes : New
Revision No. : 00
Prepared By Checked By Reviewed By Approved By Effective Date Review Date
Concerned Dept Concerned Dept QA QA-Head

9. Abbreviations

SPL - Solitaire Pharmacia Pvt. Ltd., Baddi.

QA - Quality Assurance

ICH - International Conference on Harmonization

SOP - Standard Operating Procedure

STP - Standard Testing Procedure

DQ - Design Qualification

IQ - Installation Qualification

OQ - Operational Qualification

PQ - Performance Qualification

LC - Life Cycle

10. Revision History

Revision No. Effective Date Reason for Revision

00 New Document

Format No.SPL/QA/001
 SOLITAIRE PHARMACIA PVT. LTD.
RESTRICTED CIRCULATION
STANDARD OPERATING PROCEDURE AUTHORISED PERSONS ONLY

Title: Document Preparation, Control and Retention

SOP. No. : SPL/ SOP/QA/002

Prepared By Checked By Reviewed By Approved By

Concerned Dept Concerned Dept QA QA-Head

Format /Logbook Issuance Record

Format No. SPL/QA/008
Format No. of Formats Departmen Date Total Issued Issued Retrieve Retrieve
No. and logbooks t of Page By To d on d
/Books/Pads Issue s (Date) By(sign)
Issued

Format No.SPL/QA/001