Guidelines for Testing and Release of Finished Vaginal Dosage Forms
1) Purpose
The purpose of this SOP is to outline the procedures for testing and releasing finished vaginal dosage forms to ensure that they meet specified quality standards before distribution.
2) Scope
This SOP applies to all personnel involved in the testing and release of finished vaginal dosage forms in the pharmaceutical manufacturing facility.
3) Responsibilities
The Quality Control (QC) Department is responsible for conducting all necessary tests on the finished products. The Quality Assurance (QA) Department is responsible for reviewing the test results and authorizing the release of the finished products.
4) Procedure
4.1 Receipt of Finished Products for Testing
- Receive the finished vaginal dosage forms from the manufacturing department along with the batch record and sampling documentation.
- Verify the integrity of the samples and ensure they are stored under appropriate conditions until testing is performed.
4.2 Testing of Finished Products
- Perform all required tests on the finished products as per the standard test methods and specifications outlined in the product’s master formula.
- Tests may include, but are not limited to, appearance, weight variation, content uniformity, dissolution, microbial limits, and potency.
- Document all test results in the QC test report.
- If any test results are out-of-specification (OOS), initiate an OOS investigation as per the relevant SOP.
4.3 Review and Approval of Test Results
- QA Department reviews the QC test reports to ensure all tests were performed and results meet the product specifications.
- Investigate any deviations or OOS results and document corrective actions taken.
- Upon satisfactory review, the QA Department signs off on the batch record and authorizes the release of the finished products.
4.4 Release of Finished Products
- Once approved by QA, the finished products are moved to the release storage area.
- Update inventory records to reflect the release status of the batch.
- Ensure that the released products are labeled and packaged appropriately for distribution.
4.5 Documentation
- Maintain all QC test reports, batch records, and release authorizations as part of the product’s documentation.
- Ensure that all documents are signed, dated, and filed according to the company’s document control procedures.
- Retain records as required by regulatory standards and company policy.
5) Abbreviations, if any
QC: Quality Control
QA: Quality Assurance
OOS: Out-of-Specification
6) Documents, if any
Batch records, QC test reports, release authorization forms
7) Reference, if any
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, WHO Good Manufacturing Practices: main principles for pharmaceutical products
8) SOP Version
Version 1.0
