Standard Operating Procedure for Preparing Batch Packing Records for Capsules

Department	Packaging
SOP No.	SOP/PKG/219/2025
Supersedes	SOP/PKG/219/2022
Page No.	Page 1 of 5
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

The purpose of this SOP is to define the procedure for preparing Batch Packing Records (BPRs) for capsules. The BPR ensures that all packaging steps, materials, and processes are documented and compliant with GMP and regulatory requirements.

2. Scope

This SOP applies to the preparation of Batch Packing Records for all batches of capsules produced at the facility. It includes the documentation of all packaging activities, including the materials used, packaging equipment, and batch labeling.

3. Responsibilities

• Packaging Team: Responsible for completing the BPR during the capsule packaging process and ensuring that all packaging details are documented accurately.
• Quality Control (QC) Team: Ensures that the BPR is reviewed for accuracy and completeness before batch release.
• Quality Assurance (QA) Team: Reviews and approves the BPR to ensure compliance with GMP and regulatory standards.

4. Accountability

The Packaging Manager is accountable for overseeing the BPR preparation process. The QA Manager is responsible for reviewing and approving the BPR before the batch is released for distribution.

5. Procedure

5.1 Preparation of Batch Packing Record

Follow the steps below to prepare the BPR:

1. Review Batch Information
   1. Obtain the batch number, product specifications, and batch size from the Production team.
   2. Verify that the batch size is consistent with the manufacturing order and production plan.
2. Document Packaging Materials
   1. List all packaging materials used, including bottles, blister packs, foil, and labels.
   2. Ensure that the batch numbers, supplier information, and quantities of packaging materials are recorded in the BPR.
3. Record Packaging Process Details
   1. Document the packaging steps, including the type of packaging used (e.g., blister packs, bottles), machine settings, and packaging equipment used during the process.
   2. Ensure that the number of capsules packed, and the packaging line speed, are accurately recorded.
4. Include Labeling Information
   1. Document the details of labeling, including the batch number, product name, manufacturing date, expiry date, and regulatory markings.
   2. Verify that the correct labels are applied to the packaging and that they comply with regulatory requirements.
5. Include In-Process Checkpoints
   1. Record any in-process quality checks performed during the packaging process, such as checking for labeling accuracy, filling levels, or package integrity.
   2. If any issues are detected, document the corrective actions taken.

5.2 Review of Batch Packing Record

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

1. Review by Packaging Team
   1. The Packaging team must review the BPR for completeness and accuracy. Verify that all necessary details are recorded, and that the batch number, packaging materials, and process steps are consistent.
2. Review by Quality Control
   1. The QC team reviews the BPR for accuracy, ensuring that in-process quality checks have been recorded and that all packaging materials meet specifications.
   2. Ensure that any deviations are documented and appropriate corrective actions are noted.
3. Approval by Quality Assurance
   1. The QA team reviews the BPR to ensure compliance with GMP and regulatory requirements.
   2. The QA team will approve the BPR, indicating that the batch is ready for release.

5.3 Batch Record Storage and Archiving

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

1. Store BPR
   1. Store the BPR in a secure location, either digitally or physically, according to the company’s record-keeping policies.
   2. Ensure that the BPR is stored in an organized and easily accessible manner for future reference or audits.
2. Maintain Records for Audits
   1. Ensure that the BPR is available for internal and external audits, as required by regulatory authorities.
   2. Ensure that records are retained for the required period (usually 5 years or as per local regulations).

6. Abbreviations

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

7. Documents

1. Annexure 1: Batch Packing Record Template
2. Annexure 2: Packaging Material Log
3. Annexure 3: In-Process Quality Check Record

8. References

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

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 Packing Record Template

Batch Number	Product Name	Batch Size	Packaging Date	Packaging Material	Remarks
Batch 001	Capsule A	10,000 units	02/03/2025	Bottle, 100-count	Completed successfully

Annexure 2: Packaging Material Log

Material Name	Batch Number	Supplier	Quantity Used	CoA Status
Label	Batch 001	Supplier X	10,000 labels	Verified

Annexure 3: In-Process Quality Check Record

Check Parameter	Initial Value	Final Value	Test Date	Remarks
Fill Weight	0.5 g	0.5 g	02/03/2025	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 preparing BPR	QA Head
01/02/2025	2.0	Updated packaging process documentation	Incorporated new labeling and in-process quality check procedures	QA Head