Standard Operating Procedure for Documentation and Record Keeping in Manufacturing

1) Purpose

The purpose of this SOP is to establish guidelines for the documentation and recordkeeping practices in pharmaceutical manufacturing to ensure accuracy, traceability, and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in documentation and recordkeeping activities within the pharmaceutical manufacturing facility.

3) Responsibilities

3.1 Production Personnel

• Complete batch records and other manufacturing documentation accurately and timely.
• Ensure records are reviewed and approved by authorized personnel.

3.2 Quality Assurance (QA) Personnel

• Review and verify documentation for compliance with SOPs and regulatory standards.
• Archive and maintain records as per retention schedules.

4) Procedure

4.1 Documentation Practices

1. Use approved forms and templates for documenting manufacturing activities.
2. Record all critical steps, measurements, and observations during production.

4.2 Review and Approval

1. Review batch records and other documentation for completeness and accuracy.
2. Obtain appropriate approvals before releasing products or materials.

4.3 Record Keeping

1. Maintain organized and secure storage of manufacturing records.
2. Ensure records are accessible for audits and inspections.

4.4 Document Control

1. Implement version control and document change management procedures.
2. Archive obsolete or superseded documents as per document retention policies.

5) Abbreviations, if any

SOP: Standard Operating Procedure; QA: Quality Assurance

6) Documents, if any

• Batch Production Records
• Document Change Requests
• Document Retention and Destruction Log

7) Reference, if any

21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0