Standard Operating Procedure for Batch Release Procedures in Vaginal Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to outline the procedure for the release of batches of vaginal dosage forms for distribution or further processing.

2) Scope

This SOP applies to the Quality Assurance (QA) Department responsible for ensuring that batches of vaginal dosage forms comply with all regulatory requirements and internal quality standards before release.

3) Responsibilities

The QA Department is responsible for reviewing batch documentation, conducting final checks, and authorizing the release of batches. The Production Department is responsible for notifying QA when batches are ready for release.

4) Procedure

4.1 Notification of Batch Readiness

1. The Production Department notifies QA when a batch of vaginal dosage forms is ready for release.

4.2 Documentation Review

1. QA reviews the batch documentation, including batch records, testing results, deviations, and any other relevant documentation.
2. Verify that all required tests and inspections have been performed and documented according to approved procedures.

4.3 Compliance Check

1. Ensure that the batch complies with all applicable specifications, including identity, strength, purity, and quality attributes.
2. Verify compliance with GMP requirements and regulatory filings.

4.4 Decision Making

1. Based on the review and compliance verification, QA makes a decision to release or reject the batch.
2. If the batch meets all requirements,