Standard Operating Procedure for Maintaining Cleaning Logs for Capsule Equipment

Department	Production
SOP No.	SOP/PD/220/2025
Supersedes	SOP/PD/220/2022
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 maintaining cleaning logs for capsule manufacturing equipment. The cleaning logs ensure that all equipment used in the production of capsules is thoroughly cleaned, documented, and compliant with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all capsule manufacturing equipment that requires cleaning, including but not limited to capsule filling machines, sealing machines, and granulation equipment. It covers the procedure for documenting cleaning activities to ensure equipment hygiene and GMP compliance.

3. Responsibilities

• Production Team: Responsible for performing cleaning procedures on equipment and maintaining accurate cleaning logs.
• Quality Control (QC) Team: Responsible for reviewing cleaning logs to ensure that cleaning procedures are followed correctly.
• Quality Assurance (QA) Team: Responsible for approving and ensuring that the cleaning logs are maintained according to GMP and regulatory standards.
• Maintenance Team: Responsible for ensuring that cleaning equipment (e.g., washers) is properly maintained and operational.

4. Accountability

The Production Manager is accountable for ensuring that cleaning procedures are followed and that cleaning logs are properly maintained. The QA Manager is responsible for approving and auditing cleaning logs to ensure compliance with GMP.

5. Procedure

5.1 Preparing for Cleaning

Follow these steps before cleaning the equipment:

1. Ensure Equipment is Disassembled (if required)
   1. Disassemble any removable parts of the equipment (e.g., hopper bins, feeders, and nozzles) to facilitate thorough cleaning.
   2. Verify that all parts that come into direct contact with the product are accessible for cleaning.
2. Ensure Availability of Cleaning Materials
   1. Ensure that all necessary cleaning materials, such as cleaning agents, brushes, wipes, and water, are available and in sufficient quantities.
   2. Confirm that the cleaning agents used are approved for the intended purpose and are compliant with GMP guidelines.

5.2 Cleaning Procedure

Follow the cleaning procedure outlined below:

1. Clean Equipment Thoroughly
   1. Use appropriate cleaning agents, tools, and methods to clean the equipment, ensuring that all product residues, contaminants, and debris are removed.
   2. Ensure that the cleaning process includes areas that are in direct contact with the capsule fill material and any other exposed surfaces.
2. Rinse and Dry
   1. After cleaning, rinse the equipment with water to remove any cleaning agents, ensuring that no residues are left behind.
   2. Dry all cleaned components thoroughly, using appropriate methods (e.g., air drying, clean cloths), to prevent microbial growth.
3. Inspect Equipment
   1. Visually inspect the equipment after cleaning to ensure that it is completely clean and free from contaminants.
   2. Check for any damage to parts during cleaning or assembly that may require maintenance or replacement.

5.3 Recording Cleaning Activities

It is critical to document each cleaning activity performed on the equipment. Follow these steps:

1. Fill Out the Cleaning Log
   1. Record the following details in the cleaning log:
      • Date and time of cleaning
      • Batch number or product name cleaned
      • Equipment cleaned
      • Cleaning agents used
      • Personnel performing the cleaning
      • Inspection results (i.e., equipment condition after cleaning)
2. Signatures
   1. The personnel who performed the cleaning must sign and date the cleaning log to confirm the completion of the activity.
   2. The QA team must review and sign off on the cleaning log to ensure that all cleaning procedures have been followed and documented appropriately.

5.4 Cleaning Log Review and Storage

Once the cleaning logs are completed, follow the steps below:

1. Review Cleaning Logs
   1. The QA team must review the cleaning logs for completeness and accuracy, ensuring all required details are recorded.
   2. If any discrepancies or deviations are found, they must be investigated, and corrective actions should be taken.
2. Store Cleaning Logs
   1. Once reviewed and approved, store the cleaning logs in a secure and organized location for easy retrieval during audits and inspections.
   2. Ensure that the logs are stored for the required retention period as per regulatory guidelines (typically 5 years).

6. Abbreviations

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

7. Documents

1. Annexure 1: Cleaning Log Template
2. Annexure 2: Equipment Inspection Checklist
3. Annexure 3: Approved Cleaning Agent List

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: Cleaning Log Template

Date	Batch Number	Equipment	Cleaning Agent Used	Personnel	Inspection Result	Signatures
01/03/2025	Batch 001	Capsule Filling Machine	Agent A	John Doe	Passed	Signed

Annexure 2: Equipment Inspection Checklist

Inspection Area	Checked By	Condition	Comments
Filling Head	John Doe	Good	No issues

Annexure 3: Approved Cleaning Agent List

Cleaning Agent Name	Usage	Approval Status
Agent A	Capsule Filling Machine	Approved

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 maintaining cleaning logs	QA Head
01/02/2025	2.0	Updated procedure for recording and storing cleaning logs	Revised to include new equipment and cleaning agents	QA Head