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

1. Receive batch records from the Production Department after completion of manufacturing and packaging.
2. 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

1. Conduct a thorough review of the batch record to ensure compliance with approved procedures, specifications, and GMP requirements.
2. Verify accuracy of entries, including dates, times, signatures, and any deviations or corrective actions documented.

4.3 Documentation and Corrections

1. Document findings and observations during the review process.
2. Identify any discrepancies or non-conformances and communicate them to the Production