Standard Operating Procedure for Batch Record Review in Ointment Formulation
1) Purpose
The purpose of this SOP is to establish procedures for the review and approval of batch records in ointment formulation to ensure accuracy, completeness, and compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel responsible for reviewing and approving batch records in ointment formulation, including QA, production supervisors, and authorized personnel.
3) Responsibilities
– Quality Assurance (QA): Responsible for reviewing batch records for compliance with SOPs and regulatory requirements.
– Production Supervisors: Responsible for preparing batch records and documenting production activities.
– Authorized Personnel: Responsible for approving batch records prior to product release.
4) Procedure
1. Batch Record Preparation:
1.1 Documentation Requirements:
1.1.1 Prepare batch records according to approved batch manufacturing instructions (BMIs).
1.1.2 Include all required information such as raw materials, equipment used, and process parameters.
1.2 Review of Preparatory Steps:
1.2.1 Verify completeness and accuracy of batch record entries before starting production.
1.2.2 Ensure all required documentation (e.g., equipment calibration, raw material verification) is current.
2. Production and In-process Monitoring:
2.1 Recording Production Activities:
2.1.1 Document production activities as per defined procedures and timelines.
2.1.2 Record in-process monitoring data, including critical process parameters and environmental conditions.
2.2 Sampling and Testing:
2.2.1 Collect samples for in-process testing and quality control analysis.
2.2.2 Ensure samples are labeled, handled, and stored according to SOPs.
3. Batch Completion and Review:
3.1 Final Review Preparation:
3.1.1 Complete all required sections of the batch record following batch completion.
3.1.2 Cross-check entries against raw data, laboratory results, and production logs.
3.2 QA Batch Review:
3.2.1 Conduct QA review of batch records to verify compliance with approved procedures.
3.2.2 Verify completeness of documentation and accuracy of data entries.
4. Approval and Release:
4.1 Authorization Process:
4.1.1 Obtain authorized personnel approval before releasing the batch for further processing or distribution.
4.1.2 Document batch release decision and approval signatures.
4.2 Documentation and Filing:
4.2.1 File approved batch records in designated document control areas.
4.2.2 Maintain batch records for specified retention periods as per regulatory requirements.
5. Batch Discrepancy Handling:
5.1 Investigation and Documentation:
5.1.1 Investigate any
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5.1.1 Investigate any discrepancies or deviations noted during batch record review.
5.1.2 Document investigation findings and corrective actions taken.
5.2 Quality Assurance Oversight:
5.2.1 Monitor batch record review process for consistency and compliance with SOPs.
5.2.2 Provide guidance and training to personnel involved in batch record review as needed.
6. Documentation and Records:
6.1 Batch Record Review Logs:
6.1.1 Maintain batch record review logs to track review activities and approvals.
6.1.2 Include batch record numbers, review dates, and reviewer signatures.
6.2 Document Control:
6.2.1 Ensure batch records are controlled and maintained in accordance with document control procedures.
6.2.2 Archive batch records after specified retention periods as per regulatory requirements.
7. Roles and Responsibilities:
7.1 QA Personnel:
7.1.1 Conduct thorough review of batch records to ensure compliance with regulatory requirements.
7.1.2 Verify accuracy of batch record entries and data integrity.
8. Abbreviations, if any
– QA: Quality Assurance
– SOP: Standard Operating Procedure
– BMI: Batch Manufacturing Instructions
9. Documents, if any
– Batch Records
– Batch Record Review Logs
– Investigation Reports
10. Reference, if any
– FDA Current Good Manufacturing Practice (CGMP) Regulations
– ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
11. SOP Version
Version 1.0