Standard Operating Procedure for Batch Record Review and Approval in Vaginal Dosage Form Manufacturing
1) Purpose
The purpose of this SOP is to define the procedure for reviewing and approving batch records to ensure compliance with established specifications and GMP requirements for vaginal dosage forms.
2) Scope
This SOP applies to the Quality Assurance (QA) Department responsible for reviewing and approving batch records for all batches of vaginal dosage forms manufactured at the facility.
3) Responsibilities
The QA Department is responsible for reviewing batch records to verify accuracy, completeness, and compliance with approved procedures and specifications. The Production Department is responsible for providing accurate and timely batch records for review.
4) Procedure
4.1 Receipt of Batch Records
- Receive batch records from the Production Department after completion of manufacturing and packaging.
- Verify that all required sections of the batch record are completed, including critical parameters, in-process controls, and packaging details.
4.2 Review of Batch Records
- Conduct a thorough review of the batch record to ensure compliance with approved procedures, specifications, and GMP requirements.
- Verify accuracy of entries, including dates, times, signatures, and any deviations or corrective actions documented.
4.3 Documentation and Corrections
- Document findings and observations during the review process.
- Identify any discrepancies or non-conformances and communicate them to the Production Department for clarification or corrective action.
4.4 Approval of Batch Records
- Once all discrepancies are resolved and the batch record is deemed compliant, approve the batch record.
- Sign and date the batch record to indicate approval.
5) Abbreviations, if any
GMP: Good Manufacturing Practice; QA: Quality Assurance
6) Documents, if any
Batch record checklist, non-conformance report, deviation log
7) Reference, if any
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, WHO Technical Report Series No. 961, Annex 2: WHO guidelines on good manufacturing practices for pharmaceutical products
8) SOP Version
Version 1.0
