1) SOP for Batch Documentation Retention

2) Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish standards for retaining batch documentation and records for the required period to ensure traceability, regulatory compliance, and support for quality investigations.

3) Scope

This SOP applies to all batch documentation and records generated during the manufacturing, testing, and distribution of pharmaceutical products within the facility.

4) Responsibilities

• Quality Assurance (QA) Department: Responsible for ensuring that batch documentation is properly stored, maintained, and readily accessible for the required retention period.
• Production and Quality Control (QC) Departments: Responsible for creating and providing complete and accurate batch documentation to QA.
• Document Control Team: Responsible for managing the archival and retrieval of batch records.

5) Procedure

1. Creation and Collection of Batch Documentation
   1. Ensure that all batch-related documentation is completed accurately and legibly by the responsible personnel.
   2. Collect batch records, including production records, QC test results, deviation reports, and any related documents.
   3. Verify that all required documentation is complete and signed off by authorized personnel.
2. Review and Approval of Batch Documentation
   1. QA reviews the batch documentation for completeness, accuracy, and compliance with regulatory and internal requirements.
   2. Identify and resolve any discrepancies or incomplete information in the batch records.
   3. Approve the batch documentation and ensure that it is signed off by the QA Manager or designee.
3. Archival of Batch Documentation
   1. Organize and prepare batch documentation for archival in a secure and controlled environment.
   2. Label and index batch records to facilitate easy retrieval and reference.
   3. Store batch documentation in a designated archival area with controlled access to prevent unauthorized handling or loss.
4. Retention Period
   1. Determine the retention period for batch documentation based on regulatory requirements, product shelf life, and company policies.
   2. Ensure that batch records are retained for at least one year after the expiration date of the product or as required by applicable regulations.
   3. Review and update the retention schedule periodically to comply with current regulations and company practices.
5. Access and Retrieval
   1. Implement a system for tracking and retrieving batch documentation as needed for audits, inspections, or investigations.
   2. Ensure that only authorized personnel have access to archived batch records.
   3. Maintain a log of all requests and access to batch documentation to ensure traceability and accountability.
6. Destruction of Batch Documentation
   1. Identify batch documentation that has reached the end of its retention period and is no longer required for legal or regulatory purposes.
   2. Obtain approval from QA management before destroying any batch records.
   3. Destroy batch documentation in a secure manner, such as shredding or incineration, to prevent unauthorized access or misuse.
   4. Maintain records of destroyed documents, including the date and method of destruction, and the personnel responsible.

6) Abbreviations, if any

• QA: Quality Assurance
• QC: Quality Control
• SOP: Standard Operating Procedure

7) Documents, if any

• Batch Production Records
• QC Test Results
• Deviation Reports
• Document Destruction Log

8) Reference, if any

• FDA 21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
• EU GMP Guidelines: EudraLex Volume 4
• Company-specific document retention policies

9) SOP Version

Version 1.0