Standard Operating Procedure for Batch Release Procedures

1) Purpose

The purpose of this SOP is to establish the procedures for the release of manufactured batches of injection products to ensure they meet all quality and regulatory requirements.

2) Scope

This SOP applies to all personnel involved in the batch release process at [Company Name] for intramuscular, subcutaneous, and intravenous injection products.

3) Responsibilities

The responsibilities of this SOP include:
– Production Department: Completing the production process and ensuring all batch documentation is accurate.
– Quality Control (QC) Department: Conducting tests and verifying that the batch meets quality standards.
– Quality Assurance (QA) Department: Reviewing batch records and approving the release of the batch.

4) Procedure

4.1 Batch Documentation Review
4.1.1 Collect all batch production records and documentation.
4.1.2 Review the documentation for completeness and accuracy.
4.2 Quality Control Testing
4.2.1 Ensure all required QC tests have been completed and results meet acceptance criteria.
4.2.2 Document and review QC test results.
4.3 Batch Record Review
4.3.1 QA to review the complete batch records, including production, QC, and any deviations or incidents.
4.3.2 Ensure all deviations and incidents have been investigated and resolved.
4.4 Batch Release Decision
4.4.1 QA to make the final decision on batch release based on the review of batch documentation and QC results.
4.4.2 Approve the batch release by signing and dating the batch release form.
4.5 Documentation
4.5.1 Maintain all batch release records, including batch documentation, QC results, and the batch release form.
4.5.2 Ensure all records are signed and dated by the responsible personnel.

5) Abbreviations, if any

– QA: Quality Assurance
– QC: Quality Control

6) Documents, if any

– Batch Production Records
– Quality Control Test Results
– Batch Release Form

7) Reference, if any

– Good Manufacturing Practices (GMP) Guidelines
– International Organization for Standardization (ISO) Standards

8) SOP Version

Version 1.0