1) SOP for Batch Release and Product Disposition

2) Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the procedures for reviewing and releasing finished batches of products for distribution, and ensuring proper product disposition to comply with regulatory requirements and maintain product quality.

3) Scope

This SOP applies to all finished products manufactured within the pharmaceutical facility and involves personnel responsible for quality control, quality assurance, and production management.

4) Responsibilities

• Quality Control (QC) personnel are responsible for testing and verifying product quality.
• Quality Assurance (QA) personnel are responsible for reviewing batch records and approving product release.
• Production personnel are responsible for preparing batch records and ensuring product disposition as per this SOP.
• Warehouse personnel are responsible for proper storage and handling of released products.

5) Procedure

1. Batch Record Review
   1. Collect all relevant batch records and documentation for the finished product.
   2. Verify that all required tests and inspections have been completed and documented.
   3. Check for any deviations or non-conformances noted during the production process.
   4. Ensure that any deviations have been investigated, documented, and resolved.
2. Quality Control Testing
   1. Perform all required QC tests on samples of the finished product as per the testing protocol.
   2. Document the results of QC tests in the batch records.
   3. Compare the test results with the product specifications to ensure compliance.
   4. If any test results are out of specification, initiate an investigation as per the OOS (Out of Specification) SOP.
3. Quality Assurance Review
   1. QA personnel review the completed batch records, including QC test results and any deviation reports.
   2. Confirm that the batch meets all specified criteria and regulatory requirements.
   3. Sign off on the batch record, indicating that the batch is approved for release.
4. Product Release
   1. QA personnel authorize the release of the approved batch for distribution.
   2. Update the inventory management system to reflect the release status of the batch.
   3. Notify the warehouse personnel of the product release.
5. Product Disposition
   1. Ensure that released products are stored in the designated storage area under appropriate conditions until distribution.
   2. For rejected batches, follow the procedure for proper segregation and disposal as per the relevant SOP.
   3. Maintain records of product disposition, including release, quarantine, and rejection status.
6. Documentation and Archiving
   1. Ensure all batch records, QC test results, and disposition documents are accurately completed and signed.
   2. Archive the documents in a secure and accessible location as per regulatory and company requirements.
   3. Ensure records are maintained for the required retention period.
7. Training
   1. Ensure all personnel involved in the batch release and product disposition process are adequately trained and competent.
   2. Maintain training records for all relevant personnel.

6) Abbreviations, if any

• SOP: Standard Operating Procedure
• QC: Quality Control
• QA: Quality Assurance
• OOS: Out of Specification

7) Documents, if any

• Batch Records
• QC Test Results
• Deviation Reports
• Product Release Forms
• Product Disposition Records

8) Reference, if any

• Current Good Manufacturing Practice (cGMP) guidelines
• Company-specific quality management and batch release policies

9) SOP Version

Version 1.0