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
- Collect samples of the finished product as per the sampling plan.
- Send samples to the Quality Control (QC) laboratory for final testing according to predefined specifications, including potency, purity, dissolution, and other relevant tests.
- Document all test results in the laboratory information management system (LIMS).
4.2 Batch Review
- Review the Batch Production Record (BPR) to ensure all manufacturing steps were completed as per the approved procedures.
- Verify that all in-process controls and critical quality attributes (CQAs) meet the specified criteria.
4.3 Acceptance or Rejection
- Compare the final product test results against predefined specifications to determine compliance.
- Approve the batch for release if it passes all tests and meets all quality criteria.
- Reject the batch if it fails any test or does not meet the criteria, quarantine it, and initiate an investigation report.
4.4 Documentation and Release
- Complete all necessary documentation, including the Certificate of Analysis (COA) and Quality Assurance Release Form.
- Authorize the release of the batch for distribution after all documentation is reviewed and approved.
- Ensure that all records are stored securely and are easily accessible for audits and inspections.
5) Abbreviations, if any
QA: Quality Assurance
QC: Quality Control
LIMS: Laboratory Information Management System
BPR: Batch Production Record
CQA: Critical Quality Attribute
COA: Certificate of Analysis
6) Documents, if any
Batch Production Records, Certificates of Analysis, Quality Assurance Release Forms, Test Result Records, Investigation Reports
7) Reference, if any
Regulatory guidelines such as FDA, EMA, ICH Q6A (Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances), and ICH Q10 (Pharmaceutical Quality System)
8) SOP Version
Version 1.0
