Standard Operating Procedure for Batch Release Procedures in Ointment Formulation

1) Purpose

The purpose of this SOP is to define procedures for the release of finished batches of ointment products, ensuring they meet all quality standards before distribution or use.

2) Scope

This SOP applies to all personnel involved in the quality control, quality assurance, and production departments responsible for batch release activities.

3) Responsibilities

– Quality Assurance (QA): Responsible for reviewing batch documentation and releasing products.
– Quality Control (QC): Responsible for conducting final testing and verification of batch quality.
– Production Staff: Responsible for completing batch records and notifying QA of batch readiness.

4) Procedure

1. Batch Documentation Review:
1.1 Completion of Batch Records:
1.1.1 Ensure all required documentation is complete and accurate, including batch production records and testing results.
1.1.2 Address any discrepancies or deviations noted during production.

1.2 QA Review:
1.2.1 QA reviews batch records to ensure compliance with SOPs and regulatory requirements.
1.2.2 Verify that all required tests and checks have been performed and documented.

2. Final Testing and Verification:
2.1 QC Testing:
2.1.1 Conduct final quality control testing as per approved specifications.
2.1.2 Ensure testing methods and equipment are validated and calibrated.

2.2 Approval Process:
2.2.1 QC reviews testing results and notifies QA of batch status.
2.2.2 QA verifies testing results and approves the batch for release.

3. Release Authorization:
3.1 Batch Release Decision:
3.1.1 QA authorizes the release of the batch based on satisfactory review of batch documentation and test results.
3.1.2 Document the batch release decision and approval.

3.2 Labeling and Packaging:
3.2.1 Ensure correct labeling of finished products with batch numbers, expiration dates, and other required information.
3.2.2 Package finished products in accordance with approved packaging specifications.

4. Documentation and Recordkeeping:
4.1 Batch Release Record:
4.1.1 Maintain batch release records, including QA approval, testing results, and any deviations.
4.1.2 Archive batch records for future reference and regulatory inspections.

5) Abbreviations, if any

– QA: Quality Assurance
– QC: Quality Control
– SOP: Standard Operating Procedure

6) Documents, if any

– Batch Production Records
– QC Testing Reports
– Batch Release Authorization Forms

7) Reference, if any

– FDA Current Good Manufacturing Practice (CGMP) Regulations
– ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0