SOP for Good Documentation Practices in Pharma Company

This document details the procedure for the Good Documentation Practices. It is the policy of Pharmaceuticals that written procedure shall be followed for the handling of the documents to meet the regulatory requirements.

This procedure is applicable at the time of preparation, recording, review, distribution, storage/disposal of the documents.

RESPONSIBILITIES

S. No	Designation	Responsibility
01	Executive  – Corporate Quality Assurance	To prepare the SOP, review the data and follow the SOP.
02	Manager – Quality Assurance	Review the data and follow the SOP.
03	Manager           –   Corporate Quality Assurance	To ensure implementation of SOP.

Retention Time of Documents

Sr. No.	Name Of Document	Retention Time
1	Quality Manual (Obsolete)/ Site Master File	1-Year
2	Laboratory Manual (Obsolete)	1-Year
3	SOP (Obsolete)	1-Year
4	Internal Audit Record	2-Years
5	External Audit Record	3-Years
6	Management Review Report	3-Years
7	Training Record Of The Personnel	2-Years
8	Interlaboratory Test Record	3-Years
9	PT-Programme Record	3-Years
10	Corrective Action Record	3-Years
11	Preventive Action Record	3-Years
12	Feedback form	3-Years
13	Customer complaints File	3-Years
14	Joint analysis Record	3-Years
15	Certified Reference Material Record	Till the Expiry of the CRM
16	Retesting Record	3-Years
17	Distilled water quality check record	1-Year
18	Action Taken Report For Non-conformity	2-years

Retention Time of the Records

Sr. No.	Name of Document	Retention Time
1	Sample Booking Record	6-Years
2	Record Of Analysis (Raw Datasheet Of Testing In Case of Drugs)	6-Years
3	Record Of Analysis (Raw Datasheet Of Testing In Case of Non- Drugs)	3 –Years
4	Calibration Record of Equipment	Till the Equipment is in use
5	Test Certificates (Office Copy) For Drugs	6 - Years
6	Validated Test Method (Obsolete)	1 -Year
7	Method validation Record	Till any amendment
8	Environment Record	1 -Year Min.
9	Instrument operation Log-Book	5 -Year Min.
10	Calibration Record for Instruments	5 -Year Min.
11	Logbook of the Equipment	5 -Year Min.
12	Verification Record of glassware	Till the glassware exists
13	Stock Solution Record	1-Year Min.
14	Equipment Maintenance Record	2 – Years
15	BPR/BMR	6 – Years
16	Stability Study Records	6 – Years

Persons along with their responsibilities are given below.

5.0 Procedure

5.1 Design and Preparation of Documents

5.1.1 The master copies of all the documents like SOPs, STP’s, specifications and test methods, BMRs, BPRs, etc. shall be controlled by the Quality Assurance department.

5.1.2 The basic format of each document shall be kept intact.

5.1.3 Each document shall have a code, Issue No., and effective date.

5.1.4 The document shall be prepared in lucid and easy-to-understand language.

5.1.5 Whenever the photocopy of the original document is used, it shall be ensured that the photocopy is clear and the text is readable.

5.1.6 If the register is used for recording purposes then each page shall have the individual number and be controlled by QA.

5.2 Recording and Review of Documents

5.2.1 Data shall be recorded directly into the document.

5.2.2 Data shall be recorded concurrently with the activity performed.

5.2.3 Post-dated or backdated documentation shall be strictly not allowed.

5.2.4 No data shall be written on scrap paper, rough paper, or personal notebooks. One is allowed to record the data in a raw data register controlled and numbered by the QA Department.

5.2.5 All the manual recording of data in the document shall be done with ‘Black Ball Pen’ only.

5.2.6 No space or column shall remain empty in the document, wherever no recording is required, N/A (Not applicable) shall be written in the respective column.

5.2.7 The word ‘do’ and ‘ “’ shall not be used during recording.

5.2.8 If a new word is to be inserted between two words, use’ ^’ to write a new word.

5.2.9 The date (Wherever applicable) shall be written as dd-mm-yy or dd-mm-yyyy.

5.2.10 In the test data sheet, the analyst shall put their names, signatures, and dates against each test performed by them. The whole data shall be cross-checked or reviewed by the section in charge and signed with name and date using ‘Black Ball Pen’ only.

5.2.11 The datasheet shall finally be checked and signed by an authorized signatory with a permanent ‘Black Ball Point Pen’ only.

5.3 Correction in wrong entries

5.3.1 If a wrong entry of data or observation in the documents is made, it shall be corrected by a single line cut with initials and date.

5.3.2 The mistake should be verified and signed by the section in charge.

5.4 Distribution of Documents

5.4.1 QA Department shall control and record the distribution of documents related to the manufacture and control of the product. It shall be done by Xeroxing the master document.

5.4.2 Each copy shall be stamped ‘Controlled Copy’ in red in the middle of the footer of the page.

5.4.3 Whenever a revised version of an existing document is issued, the existing version shall be retrieved immediately by the CQA and QA departments.

5.5  Storage /Disposal of Documents

5.5.1  All the current versions of the master documents shall be stored under the control of the CQA and QA departments.

5.5.2  Laboratory has different types of documents and records. All records/document have their current issue number. The old and previous records have specified times for their retention in the laboratory. The salvage of the relevant documents is recorded in a register/format

5.5.3    Adequate measures shall be taken to preserve all the documents in neat and clean condition.

5.5.4    All the retrieved controlled copies shall be destroyed immediately.

5.5.6   The document/record, after completion of the retention time is destroyed and disposed of by following means under the supervision of the Head of the Department.

- Shredding in a shredder

- Burying in an earthen pit

NOTE: Only the Managing Director and Chairman of the company has the authority to use a green pen.

ABBREVIATIONS

CQA: Corporate Quality Assurance

SOP: Standard Operating Procedure

FR: Format

HOD: Head of Department

CCR: Change Control Reference

Apr: April

QA:  Quality Assurance

QC:  Quality Control

HR:  Human Resources

No. :  Number

BPR:  Batch Production Record

BMR:  Batch Manufacturing Record

CRM:  Certified Reference Material

Min.: Minimum

>Good Laboratory Procedures(GLP)