Standard Operating Procedure for Batch Release and Product Release

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the systematic and controlled process of batch release and product release in the pharmaceutical manufacturing facility. This SOP ensures that each batch of pharmaceutical products undergoes thorough review, testing, and verification before being released for distribution or further use, thereby ensuring product quality and compliance with regulatory requirements.

2. Scope

This SOP applies to all personnel involved in the batch release and product release process, including quality assurance staff, quality control personnel, and production supervisors.

3. Responsibilities

• Quality Assurance (QA) Department: Responsible for reviewing batch records, test results, and product documentation to ensure compliance with product specifications and regulatory requirements.
• Quality Control (QC) Personnel: Responsible for performing tests and inspections on the batch samples as per approved procedures and documenting the results.
• Production Supervisor: Responsible for coordinating with the QA and QC teams to ensure timely release of batches.
• Regulatory Affairs: Responsible for coordinating with regulatory agencies for required approvals before product release.

4. Procedure

4.1 Batch Review and Documentation:

• Review the completed batch record and associated documentation to ensure all manufacturing steps and procedures were followed correctly.
• Verify that all required tests, inspections, and measurements have been performed and documented as per approved procedures.
• Ensure that all deviations and non-conformances are properly investigated, documented, and resolved before release.
• Document the batch review findings, including any discrepancies and corrective actions taken, for future reference.

4.2 Quality Control Testing:

• QC personnel should perform all required tests and inspections on the batch samples as per approved testing methods and specifications.
• Ensure that the testing equipment used is calibrated and in a state of proper functioning.
• Record the test results accurately and legibly in the appropriate batch documentation.
• Notify the QA department immediately if any batch fails to meet the specified quality standards.

4.3 Regulatory Compliance:

• Obtain all required regulatory approvals and certifications before releasing the batch for distribution or commercial use.
• Coordinate with the regulatory affairs department to ensure that all necessary documentation is complete and submitted as per regulatory requirements.
• Ensure that the product labeling and packaging comply with all applicable regulatory guidelines.

4.4 Batch Release Decision:

• Based on the batch review and quality control testing results, the QA department will make a decision to approve or reject the batch for release.
• If the batch meets all quality and regulatory requirements, it will be approved for release.
• If any issues or deviations are identified, appropriate corrective actions must be taken before considering the batch for release.
• Document the batch release decision, including the reasons for approval or rejection, in the batch records.

5. Abbreviations

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

6. Documents

The following documents are relevant to this SOP:

• Batch Review and Release Form
• Quality Control Test Results and Reports
• Regulatory Approvals and Certifications

7. References

No specific external references are required for this SOP as it is based on internal company procedures and regulatory guidelines.

8. SOP Version

This is version 1.0 of the SOP for Batch Release and Product Release, effective as of [Insert Date].