Standard Operating Procedure for Archiving Capsule Manufacturing Records

Department	Quality Control
SOP No.	SOP/QC/218/2025
Supersedes	SOP/QC/218/2022
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 establish a procedure for the proper archiving of capsule manufacturing records to ensure that all records are stored, maintained, and readily accessible for future reference, audits, and regulatory inspections.

2. Scope

This SOP applies to all records related to the manufacturing of capsules, including Batch Manufacturing Records (BMRs), in-process testing results, and packaging records. It covers the process of archiving these records in a secure and organized manner.

3. Responsibilities

• Quality Control (QC) Team: Responsible for ensuring that all manufacturing records are reviewed, approved, and properly archived in accordance with the company’s record-keeping policies.
• Production Team: Responsible for providing accurate and complete manufacturing records to the QC team for archiving after the production process is completed.
• Quality Assurance (QA) Team: Responsible for ensuring compliance with regulatory and company requirements for record archiving, and for reviewing archived records during audits.
• Records Management Team: Responsible for the physical or digital storage of records and ensuring their security and accessibility.

4. Accountability

The QC Manager is accountable for overseeing the archiving process and ensuring that all manufacturing records are appropriately archived. The Records Management Team is responsible for the actual storage and retrieval of the archived records.

5. Procedure

5.1 Preparation of Manufacturing Records for Archiving

Before archiving, ensure the following steps are completed:

1. Review Manufacturing Records
   1. The QC team reviews all manufacturing records, including the BMR, in-process testing data, and packaging information, to ensure completeness and accuracy.
   2. Ensure that all required signatures and dates are present, and verify that there are no missing documents or discrepancies.
2. Compile Required Documents
   1. Ensure that all relevant records are included in the batch file for archiving, including raw material information, in-process testing data, and packaging and labeling details.
   2. For digital records, ensure that all files are properly named, labeled, and organized according to the batch number and product type.

5.2 Archiving Process

Follow the procedure for archiving records:

1. Store Physical Records
   1. For paper records, ensure that they are stored in a secure location, such as a locked filing cabinet or archive room, with limited access to authorized personnel only.
   2. Organize records by batch number and production date to facilitate easy retrieval.
2. Store Digital Records
   1. For digital records, ensure that they are stored in a secure, backed-up electronic system or cloud-based storage that complies with data security protocols.
   2. Ensure that digital files are clearly named and stored in appropriate folders for easy access.
3. Ensure Long-Term Storage
   1. Records should be stored for the minimum retention period as required by regulatory authorities (typically 5 years or as per local regulations).
   2. Ensure that both physical and digital records are protected from damage, loss, or unauthorized access.

5.3 Record Retrieval and Access

When accessing archived records, follow these procedures:

1. Request for Records
   1. To retrieve archived records, submit a formal request to the Records Management team or through the digital system for access to the required documents.
   2. Ensure that the request specifies the batch number, product, and the specific records required (e.g., BMR, testing results, packaging data).
2. Access Approval
   1. Access to archived records must be authorized by the appropriate personnel (e.g., QC or QA Manager), particularly for sensitive or confidential data.
3. Retrieve Records
   1. Once access is approved, retrieve the physical or digital records from the designated storage area and provide them to the requesting department.
   2. Ensure that the records are returned to their proper storage location after use to maintain the organization of archived documents.

5.4 Deletion or Disposal of Records

Follow these steps when it is time to dispose of or delete records:

1. Determine Retention Period
   1. Ensure that records are kept for the required retention period as per regulatory guidelines (usually 5 years or as specified in the stability study protocols).
   2. At the end of the retention period, evaluate whether the records are still required for operational or legal purposes.
2. Delete or Dispose of Records
   1. For digital records, ensure proper deletion from the storage system or secure destruction, with verification that the records are no longer accessible.
   2. For physical records, ensure that the documents are securely shredded or destroyed in a manner that prevents unauthorized access to sensitive data.

6. Abbreviations

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

7. Documents

1. Annexure 1: Batch Manufacturing Record (BMR) Template
2. Annexure 2: Record Retention Log
3. Annexure 3: Record Disposal Certificate

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 Manufacturing Record (BMR) Template

Packaging Date

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

Annexure 2: Record Retention Log

Record Type	Batch Number	Retention Period	Storage Location	Disposal Date
BMR	Batch 001	5 years	File Room A1	01/03/2030

Annexure 3: Record Disposal Certificate

Record Type	Batch Number	Disposal Date	Disposal Method	Authorized Personnel
BMR	Batch 001	01/03/2030	Shredded	John Doe

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 archiving capsule manufacturing records	QA Head
01/02/2025	2.0	Updated document retention and disposal procedures	Incorporated updated storage and disposal regulations	QA Head