Standard Operating Procedure for Batch Record Review in Gels Production
1) Purpose
The purpose of this SOP is to define the procedures for reviewing and approving batch records generated during gels production to ensure accuracy, completeness, and compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in the review and approval of batch records within the pharmaceutical manufacturing facility.
3) Responsibilities
Quality Assurance (QA) Team: Review and approve batch records for compliance with SOPs and GMP standards.
Quality Control (QC) Analysts: Provide data and results for inclusion in batch records.
Production Operators: Ensure accurate documentation of production activities in batch records.
Supervisors: Provide oversight and support for batch record review and approval processes.
4) Procedure
4.1 Receipt of Batch Records
4.1.1 Upon completion of production, the Production Department submits the batch records to QA for review.
4.1.2 Ensure batch records are complete, including all required sections and signatures.
4.2 Initial Review
4.2.1 QA conducts an initial review of the batch records for completeness and compliance with SOPs.
4.2.2 Verify that all entries are clear, legible, and match supporting documentation.
4.3 Accuracy of Data and Calculations
4.3.1 Check the accuracy of data, including raw material quantities, process parameters, and QC test results.
4.3.2 Verify calculations such as yields, percentages, and any other critical parameters.
4.4 Compliance with GMP
4.4.1 Ensure batch records comply with GMP guidelines and regulatory requirements.
4.4.2 Address any deviations, discrepancies, or non-conformities identified during the review.
4.5 Approval Process
4.5.1 Once QA is satisfied with the batch record accuracy and compliance, approve the batch record.
4.5.2 Obtain signatures from authorized personnel, including QA, QC, and Production supervisors.
4.6 Document Control
4.6.1 Maintain a controlled copy of the approved batch record in the document management system.
4.6.2 Ensure batch records are archived and retained according to regulatory requirements and company policies.
5) Abbreviations, if any
SOP: Standard Operating Procedure
GMP: Good Manufacturing Practice
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
– Batch Records
– SOP for Batch Record Review
– Document Management System
7) Reference, if any
– FDA CFR 21 Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
– ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
– Company-specific batch record review procedures
8) SOP Version
Version 1.0