for overseeing the review of BMRs, ensuring that all specifications are met, and confirming that the product meets quality standards before approval for the next production stage.

4. Accountability

The Production Manager is accountable for ensuring that all production personnel adhere to the BMR instructions. The QA Manager is responsible for overseeing the review process and ensuring that BMRs are completed correctly and on time. The Laboratory Supervisor is accountable for reviewing the final BMR and confirming product quality before batch release.

5. Procedure

5.1 Pre-Production Setup

1. Ensure that the correct Batch Manufacturing Record (BMR) for the specific product is available before the start of production. The BMR should reflect the most current version, and all updates must be included.
2. Verify that the BMR is complete with all necessary sections, including raw material details, production steps, equipment specifications, and quality control checks.
3. Ensure that all personnel involved in the production process are familiar with the BMR requirements and understand their role in documenting and following the procedures outlined in the BMR.
4. Review the batch ticket or BMR for any special instructions regarding equipment settings, process parameters, or material handling that must be followed during production.

5.2 Production Process and BMR Documentation

1. During the manufacturing process, ensure that all steps outlined in the BMR are followed exactly. This includes ingredient dispensing, mixing, heating, cooling, and any other critical process steps.
2. Document all production activities, including raw material weights, equipment settings, times, and any adjustments made during the process. Each entry should include the operator’s name and the time of the entry.
3. Ensure that all quality control tests, such as viscosity, pH, and microbial testing, are documented as per the instructions in the BMR. Include results from each test and any corrective actions taken if the results deviate from the specified limits.
4. If any deviations from the BMR occur (e.g., changes in process parameters or material substitutions), these must be documented in the Deviation Report (Annexure-1) and reviewed by the QA team for approval.

5.3 BMR Review and Verification

1. Upon completion of the batch production, the BMR must be reviewed by the QA team to ensure that all steps were performed correctly and that the final product meets the quality specifications outlined in the BMR.
2. The QA team should verify that the BMR is complete and accurately reflects the entire production process. Ensure that any changes made during production (e.g., equipment adjustments, process variations) are documented and justified.
3. Confirm that all signatures on the BMR are present, including the operator, supervisor, and QC personnel, where applicable. Each section of the BMR should be signed off at the appropriate points in the production process.
4. Ensure that any deviations or exceptions documented during production are resolved before final approval. If necessary, initiate corrective or preventive actions as outlined in the CAPA (Corrective and Preventive Action) process.

5.4 Post-Production Activities

1. Once the BMR is verified and complete, the QA team will approve the batch for the next stage of production, such as filling or packaging. The batch is only approved once all criteria are met, and no unresolved deviations remain.
2. Ensure that all BMRs are archived and stored according to regulatory and company guidelines for traceability and future reference. Maintain records for a minimum of two years or as required by local regulations.

5.5 Documentation and Record-Keeping

1. Document all batch-related activities in the BMR and ensure that the record includes accurate data on raw materials, process parameters, and testing results. Use the Batch Manufacturing Record Log (Annexure-2) for tracking each batch’s documentation status.
2. Ensure that the BMR and related documents are signed by the relevant personnel and reviewed by the QA team. All records should be reviewed for completeness and accuracy before filing.
3. Ensure that any deviations from the BMR, as well as the corrective actions taken, are recorded in the Deviation Report (Annexure-1). This ensures proper documentation of any incidents and the steps taken to resolve them.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• BMR: Batch Manufacturing Record
• PPE: Personal Protective Equipment

7. Documents

1. Annexure-1: Deviation Report
2. Annexure-2: Batch Manufacturing Record Log

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• FDA Guidance for Industry: Batch Record Documentation in Pharmaceutical Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Deviation Report

Batch Number	Deviation Description	Corrective Action	Resolved By
12345	Raw material substitution	Verified with QA, batch approved	Michael Lee

Annexure-2: Batch Manufacturing Record Log

Batch Number	Document Status	Signed By	Date	Remarks
12345	Complete	John Doe	21/01/2026	Verified and signed off

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head