Standard Operating Procedure for Ensuring Traceability in Capsule Manufacturing Documentation

Department	Quality Assurance
SOP No.	SOP/QA/225/2025
Supersedes	SOP/QA/225/2022
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 ensure proper traceability of capsule manufacturing documentation. Traceability ensures that all manufacturing steps, materials, equipment, and personnel actions are documented, allowing for the complete tracking of a batch from production to final distribution.

2. Scope

This SOP applies to all documentation related to capsule manufacturing, including raw material receipt, batch records, in-process testing, packaging, and final release. It ensures that all documentation is properly linked to its corresponding batch and remains traceable for audits and regulatory inspections.

3. Responsibilities

• Quality Assurance (QA) Team: Ensures that all manufacturing documentation is complete, accurate, and traceable. QA verifies that all records are correctly linked to the corresponding batch.
• Production Team: Responsible for maintaining accurate batch records, documenting each step of the manufacturing process, and ensuring traceability between production activities.
• Warehouse Team: Ensures that all raw materials are documented with batch numbers and are traceable throughout the manufacturing process.
• Records Management Team: Responsible for the organization, storage, and retrieval of all manufacturing records to ensure they are traceable and readily available for audits.

4. Accountability

The QA Manager is accountable for overseeing the traceability of manufacturing documentation and ensuring compliance with this SOP. The Production Manager is responsible for maintaining accurate and traceable records for each batch of capsules.

5. Procedure

5.1 Documentation of Raw Materials

To ensure traceability of raw materials, follow these steps:

1. Record Raw Material Details
   1. Upon receipt, record the batch number, supplier, quantity, and lot number of each raw material in the Raw Material Receipt Log (refer to Annexure 1).
   2. Link each raw material batch to the corresponding capsule production batch for full traceability.
2. Verify Material Identification
   1. Before use in production, verify that each material is properly identified, and the documentation is complete and traceable.
   2. Ensure that materials are stored in clearly labeled areas to avoid mix-ups and facilitate traceability.

5.2 Documentation of Batch Records

To ensure traceability in the manufacturing process, follow these steps:

1. Complete Batch Manufacturing Records (BMR)
   1. For each batch of capsules, complete the Batch Manufacturing Record (BMR), including all process steps, equipment used, and operator details (refer to Annexure 2).
   2. Document each process step in real time to ensure accurate traceability from start to finish.
2. Record In-Process Testing
   1. Document all in-process testing, such as weight variation, hardness, dissolution, and other critical quality attributes.
   2. Link in-process test results to the relevant BMR and ensure traceability of each test result back to the specific batch.

5.3 Packaging Documentation

To maintain traceability during packaging, follow these steps:

1. Document Packaging Steps
   1. Document all packaging activities, including the packaging materials used (e.g., blisters, bottles, desiccants), batch numbers, and operators involved.
   2. Ensure that all packaging activities are linked to the corresponding batch through Batch Packing Records (refer to Annexure 3).
2. Labeling and Cartoning
   1. Record the labeling details for each packaging run, including label numbers and batch numbers for traceability.
   2. Ensure that the packaging batch numbers are linked to the production batch in the records.

5.4 Final Product Release and Documentation

Once the batch is finished, follow these steps for final release and documentation:

1. Review and Approve BMR
   1. The QA team must review the completed BMR, ensuring that all necessary documentation is included and that the batch complies with regulatory standards.
   2. Upon approval, sign off on the BMR, marking the batch as ready for release.
2. Record Final Product Details
   1. Record final product details, including batch number, quantity, and packaging information, in the final product release log.
   2. Ensure that all documentation for the batch is securely stored and easily accessible for traceability purposes.

5.5 Archiving and Retrieval of Records

To ensure traceability, follow these steps for record storage:

1. Secure Record Storage
   1. Store all documentation related to capsule production, including BMRs, in-process test records, and packaging records, in a secure location.
   2. Ensure that records are stored in compliance with regulatory requirements and company policies.
2. Ensure Easy Retrieval
   1. Maintain an organized filing system, whether physical or electronic, that allows for the quick retrieval of records for audits or inspections.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• BMR: Batch Manufacturing Record
• BPR: Batch Packing Record

7. Documents

1. Annexure 1: Raw Material Receipt Log
2. Annexure 2: Batch Manufacturing Record Template
3. Annexure 3: Batch Packing Record Template

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: Raw Material Receipt Log

Batch Number	Material	Quantity Received	Supplier	Date Received	Batch Release Status
Batch 001	Gelatin	500 kg	ABC Suppliers	01/03/2025	Approved

Annexure 2: Batch Manufacturing Record Template

Batch Number	Material Used	Process Steps	Test Results	Signature
Batch 001	Gelatin, API	Filling, Sealing	Pass	John Doe

Annexure 3: Batch Packing Record Template

Batch Number	Packaging Material	Quantity Packed	Operator Name	Packaging Date
Batch 001	Blister Pack	5000 Capsules	Jane Smith	02/03/2025

12. Revision History

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Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial version of SOP	Creation of SOP for ensuring traceability in documentation	QA Head
01/02/2025	2.0	Updated process for recording raw material receipt and packaging documentation	Revised to improve traceability during batch tracking and packaging	QA Head