Capsule: SOP for Inspecting Cleaned Capsule Manufacturing Equipment – V 2.0

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Capsule: SOP for Inspecting Cleaned Capsule Manufacturing Equipment – V 2.0

Standard Operating Procedure for Inspecting Cleaned Capsule Manufacturing Equipment

Department Capsule Manufacturing
SOP No. SOP/CM/149/2025
Supersedes SOP/CM/149/2022
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 provide detailed guidelines for inspecting cleaned capsule manufacturing equipment. Ensuring that all manufacturing equipment is properly cleaned and ready for use is critical to maintaining product quality and GMP compliance. This SOP outlines the procedure for inspecting the equipment to confirm that it is free of residues and contaminants before production.

2. Scope

This SOP applies to the inspection of all capsule manufacturing equipment after cleaning, including capsule filling machines, capsule sealing machines, capsule coating machines, and any other equipment used in capsule production. The procedure ensures that the equipment is free of contamination and ready for the next production run.

3. Responsibilities

  • Production Operators: Responsible for carrying out the inspection of cleaned equipment and ensuring it meets the required standards for cleanliness before use.
  • Quality Control (QC) Team: Reviews and verifies the inspection of the equipment and ensures compliance with GMP standards before the equipment is approved for use in production.
  • Quality Assurance (QA) Team: Ensures that the inspection process is followed correctly and reviews inspection records to verify compliance with regulatory requirements.
  • Maintenance Team: Assists with equipment checks to verify that all components are functioning correctly and that no issues are present after cleaning.
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4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring that all equipment is inspected and deemed clean and functional before being used in production. The QA Manager is responsible for ensuring compliance with this SOP and for reviewing the inspection documentation.

5. Procedure

5.1 Preparation for Inspection of Cleaned Equipment

Before starting the inspection, ensure that the following steps are completed:

  1. Turn Off and Isolate Equipment

    1. Ensure that all equipment is turned off and properly isolated from any power, air, or liquid supplies to prevent accidental operation during inspection.
    2. Ensure that the equipment is cool and safe to handle before inspection.
  2. Gather Inspection Tools

    1. Collect the necessary tools for inspection, including a flashlight, magnifying glass, inspection checklist (Annexure-2), and any required PPE (Personal Protective Equipment) like gloves and goggles.
  3. Verify Cleaning Documentation

    1. Review the cleaning log and post-cleaning inspection report to confirm that the equipment was cleaned according to the prescribed SOP and that no issues were noted during the cleaning process.

5.2 Inspection Process

Follow these steps to conduct the inspection of the cleaned equipment:

  1. Visual Inspection

    1. Perform a thorough visual inspection of the equipment, checking for any visible residues, stains, or contamination on all external and internal parts.
    2. Inspect areas such as caps, trays, hoppers, and seals, as well as any parts that come into contact with materials used in capsule production, including molds and filling components.
  2. Check for Residue in Hard-to-Reach Areas

    1. Use a flashlight and magnifying glass to check for any hidden residues in corners, joints, or other hard-to-reach areas.
    2. Pay special attention to areas where powder or gelatin may have accumulated and ensure that these are thoroughly cleaned.
  3. Check for Damage

    1. Check all parts of the equipment for signs of wear, damage, or degradation that may have occurred during cleaning or previous use.
    2. Look for cracks, dents, or any other physical damage that may impact the functionality or cleanliness of the equipment.
  4. Functional Check

    1. If applicable, perform a functional check to ensure that all moving parts are operating correctly, and that there are no obstructions or blockages that would hinder the equipment’s performance during production.
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5.3 Post-Inspection Documentation

After the inspection is complete, ensure that the following documentation is properly filled out:

  1. Inspection Log

    1. Record the results of the inspection in the Equipment Inspection Log (Annexure-2), including the date, operator name, equipment ID, and any observations from the inspection process.
  2. Cleaning Verification

    1. Confirm that the cleaning was completed as per the prescribed procedure, and that the equipment is free of residues and contaminants.
  3. Approval for Use

    1. If the equipment passes inspection, mark it as “Approved for Use” in the inspection log and notify the production team to proceed with the next production run.
    2. If any issues are found, document them and follow up with the maintenance team for repair or re-cleaning.

5.4 Documentation

Ensure proper documentation of the inspection process for traceability and compliance:

  1. Inspection Log

    1. Complete the inspection log for each piece of equipment, ensuring that the operator, inspection date, findings, and corrective actions (if any) are properly documented.
  2. Post-Cleaning Inspection Report

    1. Complete the Post-Cleaning Inspection Report (Annexure-3) if the inspection is part of a larger post-cleaning validation process.
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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. Equipment Inspection Log (Annexure-2)
  2. Post-Cleaning Inspection Report (Annexure-3)
  3. Cleaning Log (Annexure-1)

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-2: Equipment Inspection Log

Equipment ID Inspection Date Operator Inspection Results Corrective Action Approval Status
Machine 001 02/02/2025 John Doe Clean and operational No corrective action needed Approved for use

Annexure-3: Post-Cleaning Inspection Report

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

Annexure-1: Cleaning Log

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

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 inspection process Enhanced inspection procedures QA Head
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