Capsule: SOP for Ensuring Cleaning Documentation for Capsule Equipment – V 2.0

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Capsule: SOP for Ensuring Cleaning Documentation for Capsule Equipment – V 2.0

Standard Operating Procedure for Ensuring Cleaning Documentation for Capsule Equipment

Department Capsule Manufacturing
SOP No. SOP/CM/143/2025
Supersedes SOP/CM/143/2022
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 outline the process for ensuring proper cleaning documentation for capsule manufacturing equipment. It is crucial to maintain accurate and thorough records of all cleaning activities to comply with GMP guidelines, ensure product safety, and guarantee that equipment remains contaminant-free between production cycles. This SOP ensures that all cleaning actions, inspections, and verifications are well-documented for traceability and audit purposes.

2. Scope

This SOP applies to all cleaning documentation related to capsule manufacturing equipment, including capsule filling machines, blenders, granulators, and other equipment used in the production process. It covers the recording of cleaning dates, operators, cleaning actions, and any observations or issues encountered during cleaning.

3. Responsibilities

  • Production Operators: Responsible for documenting cleaning activities performed on equipment, ensuring that all fields are filled accurately in the cleaning logs and inspection reports.
  • Cleaning Staff: Assist with the documentation of cleaning activities, particularly when working with production operators to ensure proper recording of cleaning actions.
  • Quality Control (QC) Team: Ensures that all cleaning documentation is complete and accurate, verifies that cleaning actions meet required standards, and reviews documentation for compliance with GMP guidelines.
  • Quality Assurance (QA) Team: Oversees the cleaning documentation process to ensure compliance with regulatory requirements and GMP standards, ensuring that all records are properly maintained and reviewed.
  • Production Supervisor: Ensures that all equipment cleaning documentation is completed accurately and timely and verifies that no discrepancies are present in the cleaning records.
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4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring that cleaning documentation for all capsule production equipment is complete and accurate. The QA Manager oversees compliance with this SOP and verifies the integrity of the cleaning documentation to ensure it meets GMP standards.

5. Procedure

5.1 Collection of Cleaning Data

Before cleaning the equipment, the following steps should be followed:

  1. Identify Equipment to be Cleaned

    1. Identify all equipment that requires cleaning following production. This may include capsule filling machines, blenders, granulators, and any other equipment used in the manufacturing process.
  2. Prepare Cleaning Documentation

    1. Ensure that the appropriate cleaning logs and inspection forms are available for documenting cleaning actions (see Annexure-1 and Annexure-2).
    2. Verify that the logs are current and contain all necessary fields, including equipment identification, operator name, cleaning date, cleaning actions performed, and any issues encountered.

5.2 Performing Cleaning and Documenting the Process

During the cleaning process, the following actions must be documented:

  1. Document Cleaning Actions

    1. As cleaning actions are performed, document each step clearly, including the type of cleaning (e.g., manual cleaning, wash-in-place, clean-in-place), materials used, and the operator’s name.
    2. Indicate the date and time of the cleaning action in the cleaning log.
  2. Inspect for Residues

    1. After the cleaning is complete, perform a visual inspection of the equipment to ensure it is free from cleaning residues, dust, or product build-up.
    2. Record any issues identified during the inspection and ensure corrective actions are documented in the cleaning log (e.g., re-cleaning, repair needed).
  3. Complete Cleaning Documentation

    1. Once the cleaning is completed, ensure that all sections of the cleaning log are filled out completely and correctly.
    2. Ensure that the cleaning log includes operator signatures, date, and any relevant notes or comments regarding the cleaning procedure.
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5.3 Post-Cleaning Review and Documentation Verification

After cleaning, the following review steps must be completed:

  1. QC Review of Cleaning Logs

    1. The QC team should review the completed cleaning logs to ensure all fields are correctly filled out, and there are no discrepancies.
    2. QC should verify that the documented cleaning actions align with the SOP for cleaning equipment and that no steps have been skipped.
  2. QA Final Verification

    1. The QA team will perform a final review of the cleaning documentation to ensure compliance with GMP and regulatory standards.
    2. QA should check that all necessary corrective actions, if any, have been documented and resolved before the equipment is returned to use.

5.4 Documentation Retention

Ensure proper storage and retention of all cleaning documentation:

  1. File Cleaning Logs and Inspection Reports

    1. After approval, file the cleaning logs and inspection reports in a secure location for future reference.
    2. Ensure that all documentation is easily accessible for internal audits or external inspections.
  2. Maintain Documentation for Regulatory Compliance

    1. Cleaning logs must be maintained for a minimum of three years or as required by local regulations or company policies.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • PPE: Personal Protective Equipment

7. Documents

  1. Cleaning Log (Annexure-1)
  2. Post-Cleaning Inspection Report (Annexure-2)

8. References

  • USP <1163> – Pharmaceutical Dosage Forms: Capsules
  • FDA Guidelines for Capsule Manufacturing
  • Good Manufacturing Practice (GMP) Guidelines

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

Batch ID Cleaning Date Operator Cleaning Action Comments
Batch 001 02/02/2025 John Doe Completed cleaning of equipment No issues found

Annexure-2: Post-Cleaning Inspection Report

Equipment ID Inspection Date Inspection Results Operator Next Maintenance Due
Equipment 001 02/02/2025 Clean and ready for use Jane Smith 02/02/2026

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial version New SOP Creation QA Head
01/02/2025 2.0 Updated documentation process Improved compliance tracking QA Head
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