Standard Operating Procedure for Finished Product Quality Assurance

1) Purpose

This SOP outlines the procedures for ensuring the quality of finished pharmaceutical products before they are released for distribution to ensure they meet all regulatory and company quality standards.

2) Scope

This SOP applies to all finished products manufactured within the company that are ready for final testing, review, and release.

3) Responsibilities

The Quality Assurance (QA) department is responsible for implementing and maintaining this SOP. The QA team ensures that all finished products meet specified quality criteria before release.

4) Procedure

4.1 Final Product Testing

1. Collect samples of the finished product as per the sampling plan.
2. Send samples to the Quality Control (QC) laboratory for final testing according to predefined specifications, including potency, purity, dissolution, and other relevant tests.
3. Document all test results in the laboratory information management system (LIMS).

4.2 Batch Review

1. Review the Batch Production Record (BPR) to ensure all manufacturing steps were completed as per the approved procedures.
2. Verify that all in-process controls and critical quality attributes (CQAs) meet the specified criteria.

4.3 Acceptance or Rejection

1. Compare the final product test results against predefined specifications to determine compliance.
2. Approve the batch for release if it passes all tests and meets all quality criteria.
3. Reject the batch