Standard Operating Procedure for Batch Manufacturing Record for Gels
1) Purpose
The purpose of this SOP is to outline the procedures for creating, maintaining, and reviewing Batch Manufacturing Records (BMR) for gels to ensure accurate documentation and traceability of each production batch.
2) Scope
This SOP applies to all personnel involved in the production, quality control, and quality assurance of gels within the pharmaceutical manufacturing facility.
3) Responsibilities
Production Operators: Accurately document each step of the manufacturing process in the BMR.
Quality Control (QC) Analysts: Review the BMR to ensure all required tests and inspections are documented.
Quality Assurance (QA) Team: Review and approve the completed BMR for compliance with GMP and company standards.
4) Procedure
4.1 Preparation of BMR
4.1.1 The BMR template should be prepared by the QA team, including all necessary sections for documenting the manufacturing process.
4.1.2 Ensure the BMR template includes sections for raw material information, equipment used, process steps, in-process checks, and QC results.
4.2 Recording Manufacturing Details
4.2.1 Production operators must fill out the BMR in real-time, recording details such as:
4.2.1.1 Batch number and date of manufacture.
4.2.1.2 Raw material batch numbers, quantities, and lot numbers.
4.2.1.3 Equipment used, including calibration status.
4.2.1.4 Detailed process steps, including times, temperatures, and any deviations.
4.2.1.5 In-process checks and their results.
4.3 Quality Control Checks
4.3.1 QC analysts must document all tests conducted on the batch, including:
4.3.1.1 Sample collection times and conditions.
4.3.1.2 Test results and any observations.
4.3.1.3 Approval or rejection of the batch based on test results.
4.4 Review and Approval
4.4.1 The completed BMR should be reviewed by the QA team for accuracy and completeness.
4.4.2 Any discrepancies or deviations should be investigated and documented.
4.4.3 The BMR should be signed off by the responsible personnel, including production, QC, and QA.
4.5 Documentation and Archiving
4.5.1 Store the approved BMR in a secure and accessible location.
4.5.2 Maintain BMRs for the required retention period as per regulatory guidelines and company policy.
5) Abbreviations, if any
SOP: Standard Operating Procedure
BMR: Batch Manufacturing Record
QC: Quality Control
QA: Quality Assurance
GMP: Good Manufacturing Practice
6) Documents, if any
– Batch Manufacturing Record Template
– In-Process Checklists
– QC Test Records
7) Reference, if any
– ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
– FDA CFR 21 Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
– Company-specific guidelines on batch record documentation
8) SOP Version
Version 1.0
