1.0 Purpose
The purpose of this Standard Operating Procedure (SOP) is to provide a systematic and standardized process for the review of Batch Manufacturing Records (BMR) to ensure accuracy, compliance with established procedures, and adherence to regulatory requirements. This SOP outlines the responsibilities, process, and documentation requirements for the BMR review at [Your Company Name].
2.0 Scope
This SOP applies to all personnel involved in the review of Batch Manufacturing Records for all products manufactured at [Your Company Name] facility. The BMR review process encompasses the stages from the completion of manufacturing through to final product release.
3.0 Definitions
- BMR (Batch Manufacturing Record): A comprehensive document containing step-by-step instructions and detailed information related to the production, packaging, and control of a specific batch of a product.
- QA (Quality Assurance): The department responsible for ensuring compliance with cGMP (current Good Manufacturing Practices) and quality standards.
4.0 Responsibilities
4.1 The Production Department shall be responsible for:
- Completing the BMR accurately and completely, following the approved manufacturing procedures and instructions.
- Ensuring all critical data, process parameters, and in-process checks are appropriately recorded in the BMR.
- Submitting the completed BMR to the QA Department for review.
4.2 The Quality Assurance (QA) Department shall be responsible for:
- Reviewing the BMR for compliance with approved procedures, cGMP guidelines, and regulatory requirements.
- Verifying the accuracy and completeness of the recorded information, including any deviations or changes during the manufacturing process.
- Initiating investigations for any identified discrepancies or deviations.
- Approving or rejecting the BMR based on the review findings.
5.0 Procedure
5.1 BMR Review Initiation:
- Upon the completion of manufacturing and relevant in-process checks, the Production Department shall prepare the BMR.
- The Production Department shall forward the completed BMR to the QA Department for review.
5.2 BMR Review Process:
- QA personnel shall promptly initiate the review process upon receipt of the BMR.
- The review shall include a thorough examination of the BMR for completeness, accuracy, and adherence to approved procedures.
- QA shall ensure that all manufacturing steps, including critical process parameters and equipment usage, are correctly documented.
- Any deviations, discrepancies, or non-conformances identified during the review shall be recorded, and further investigations shall be initiated.
5.3 Deviations and Investigations:
- If any deviations or discrepancies are found during the review, QA shall promptly communicate with the Production Department to initiate investigations.
- The Production Department shall conduct a detailed investigation into the identified issues, including root cause analysis and implementation of appropriate corrective actions.
- QA shall review and assess the investigation report to determine if the batch can be released or if additional actions are required.
5.4 Approval and Batch Release:
- Once QA is satisfied that the BMR is accurate, complete, and compliant with all relevant procedures and guidelines, they shall approve the BMR.
- The QA-approved BMR is a critical document for the final release of the batch.
- Only after QA approval, the product batch is eligible for release and distribution.
6.0 Documentation
All BMR review activities, findings, investigations, and approvals shall be documented in the appropriate records and maintained as part of the batch record and quality documentation.
7.0 Training
All personnel involved in the BMR review process shall be appropriately trained on this SOP and any related procedures.
8.0 Change Control
Any changes to this SOP shall follow the established Change Control procedure and be approved by the Quality Assurance Manager.
9.0 Records Retention
All BMR review records shall be retained in accordance with the document retention policy of [Your Company Name].
10.0 References
List any applicable Standard Operating Procedures, guidelines, or regulations related to BMR review.
This SOP is effective upon approval and supersedes any previous versions. Any deviations from this SOP must be approved by the Quality Assurance Manager.
Signature: ____________________________
Printed Name: _________________________
Date: __________________________________
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