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
- The Production Department notifies QA when a batch of vaginal dosage forms is ready for release.
4.2 Documentation Review
- QA reviews the batch documentation, including batch records, testing results, deviations, and any other relevant documentation.
- Verify that all required tests and inspections have been performed and documented according to approved procedures.
4.3 Compliance Check
- Ensure that the batch complies with all applicable specifications, including identity, strength, purity, and quality attributes.
- Verify compliance with GMP requirements and regulatory filings.
4.4 Decision Making
- Based on the review and compliance verification, QA makes a decision to release or reject the batch.
- If the batch meets all requirements, QA authorizes the release of the batch for distribution or further processing.
5) Abbreviations, if any
QA: Quality Assurance; GMP: Good Manufacturing Practice
6) Documents, if any
Batch release checklist, batch release authorization form
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
