Standard Operating Procedure for Preparing Batch Manufacturing Records for Capsules

Department	Production
SOP No.	SOP/PD/216/2025
Supersedes	SOP/PD/216/2022
Page No.	Page 1 of 6
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

The purpose of this SOP is to establish a standardized procedure for preparing Batch Manufacturing Records (BMRs) for capsule production. The BMR ensures that all manufacturing processes are documented, compliant with GMP, and traceable.

2. Scope

This SOP applies to the preparation of Batch Manufacturing Records for capsules at our facility. It covers the documentation of all steps in the manufacturing process, from the receipt of raw materials to the final packaging.

3. Responsibilities

• Production Team: Responsible for preparing the BMR during the capsule manufacturing process, ensuring that all necessary information is documented accurately.
• Quality Control (QC) Team: Ensures that the BMR is reviewed for accuracy and completeness before batch release.
• Quality Assurance (QA) Team: Reviews and approves the BMR, ensuring compliance with GMP and regulatory standards.
• Packaging Team: Responsible for ensuring that the packaging details are accurately recorded in the BMR.

4. Accountability

The Production Manager is accountable for ensuring that BMRs are accurately prepared and all necessary records are maintained during the manufacturing process. The Quality Assurance Manager is accountable for approving the BMR to ensure it meets regulatory requirements.

5. Procedure

5.1 Preparation of Batch Manufacturing Record

Follow the steps to prepare the BMR:

1. Review Batch Information
   1. Gather all relevant information for the batch, including batch number, product specifications, raw materials, and manufacturing dates.
   2. Ensure that the product formula and batch sizes are correct as per the production order.
2. Document Raw Materials
   1. List all raw materials used in the production, including the name, batch number, quantity used, and supplier details.
   2. Ensure that the Certificate of Analysis (CoA) for each raw material is included and meets required specifications.
3. Include Manufacturing Process Details
   1. Document each step of the manufacturing process, including granulation, blending, capsule filling, and sealing.
   2. Ensure that equipment used, operators, and any deviations are recorded in the BMR.
4. Include In-Process Testing Results
   1. Include results from in-process tests, such as tablet weight, fill volume, hardness, dissolution, and other quality checks performed during production.
   2. Ensure all testing results meet the pre-defined specifications.
5. Include Packaging Information
   1. Document packaging details, including the type of packaging used, quantity per container, and labeling information.
   2. Ensure that the batch numbers and expiry dates are clearly marked on the packaging.

5.2 Batch Record Review

Once the BMR is completed, the following review process must be followed:

1. Review by Production
   1. The Production team must review the BMR for completeness and accuracy. Ensure that all required sections are filled out and that there are no discrepancies in the data.
   2. Verify that all manufacturing steps, materials, and equipment are documented correctly.
2. Review by Quality Control
   1. The QC team must verify that the in-process testing results meet the specifications and that any deviations are documented with appropriate corrective actions.
3. Approval by Quality Assurance
   1. The QA team must review the BMR to ensure that it complies with GMP guidelines and regulatory requirements.
   2. The QA team will approve the BMR, indicating that the batch is ready for release and distribution.

5.3 Batch Record Storage and Archiving

Once the BMR is reviewed and approved, ensure the following steps:

1. Store the BMR
   1. Store the BMR in a secure, easily accessible location for future reference, in accordance with the company’s archiving policy.
   2. Ensure the BMR is kept in a controlled environment to prevent damage or loss.
2. Maintain Records for Audits
   1. Ensure that all BMRs are available for internal and external audits as per regulatory requirements.
   2. Maintain records of all BMRs for a minimum of five years, or as required by regulatory authorities.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• BMR: Batch Manufacturing Record
• QC: Quality Control
• QA: Quality Assurance
• CoA: Certificate of Analysis

7. Documents

1. Annexure 1: Batch Manufacturing Record Template
2. Annexure 2: Raw Material Batch Verification Log
3. Annexure 3: In-Process Testing Record

8. References

• Good Manufacturing Practice (GMP) Guidelines
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure 1: Batch Manufacturing Record Template

Batch Number	Product Name	Batch Size	Manufacturing Date	Packaging Date	Remarks
Batch 001	Capsule A	10,000 units	01/03/2025	02/03/2025	Completed successfully

Annexure 2: Raw Material Batch Verification Log

Material Name	Batch Number	Supplier	Quantity Used	CoA Status
API A	Batch 123	Supplier X	5 kg	Verified

Annexure 3: In-Process Testing Record

Test Parameter	Initial Value	Test Date	Final Value	Remarks
Weight	0.5 g	01/03/2025	0.5 g	Within specification

12. Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial version of SOP	Creation of SOP for BMR preparation	QA Head
01/02/2025	2.0	Updated documentation process	Incorporated changes to include packaging details and in-process testing	QA Head