Capsule: SOP for Use of Personal Protective Equipment in Dispensing Areas – V 2.0

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Capsule: SOP for Use of Personal Protective Equipment in Dispensing Areas – V 2.0

Standard Operating Procedure for Use of Personal Protective Equipment in Dispensing Areas

Department Capsule Manufacturing
SOP No. SOP/CM/019/2025
Supersedes SOP/CM/019/2022
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 define the procedures for the use of Personal Protective Equipment (PPE) in the dispensing areas of capsule manufacturing to ensure the safety of personnel and the protection of products from contamination.

2. Scope

This SOP applies to all personnel working in the dispensing areas where materials, including APIs and excipients, are handled during capsule manufacturing.

3. Responsibilities

  • Manufacturing Personnel: Responsible for wearing and maintaining the appropriate PPE while working in the dispensing areas and following all PPE-related procedures.
  • Quality Control (QC) Team: Ensures that PPE usage complies with this SOP and monitors adherence to PPE standards in dispensing areas.
  • Quality Assurance (QA) Team: Oversees the compliance with PPE usage in the dispensing areas, ensuring that procedures are followed and corrective actions are taken when necessary.
  • Health and Safety Officer: Ensures that appropriate PPE is available for all personnel and that staff is trained on the correct use of PPE in the dispensing areas.

4. Accountability

The Manufacturing Supervisor is accountable for ensuring that all personnel in the dispensing areas use appropriate PPE. The QA Manager is responsible for ensuring compliance and monitoring adherence to this SOP.

5. Procedure

5.1 Types of Personal Protective Equipment (PPE)

Ensure the correct selection of PPE for the dispensing areas:

  1. Protective Clothing

    1. Wear clean, disposable gowns, aprons, or lab coats to prevent contamination of products and protect personnel from exposure to hazardous materials.
    2. Ensure that clothing is designed to cover the arms and legs completely, with no exposed skin in dispensing areas.
  2. Gloves

    1. Wear disposable gloves (latex, nitrile, or vinyl) when handling materials, APIs, excipients, or any equipment in the dispensing areas.
    2. Ensure that gloves are regularly inspected for damage and replaced when necessary.
  3. Face Masks

    1. Wear disposable face masks to prevent contamination of the materials and products, especially when handling open containers of materials or powders.
    2. Ensure masks are correctly fitted and provide a barrier to airborne contaminants.
  4. Eye Protection

    1. Wear safety glasses or goggles when handling powders or liquids that could potentially cause eye irritation or injury.
    2. Ensure that eye protection fits comfortably and provides adequate coverage for the eyes.
  5. Footwear

    1. Wear closed-toe shoes or boots that provide a barrier against spills and accidental contact with hazardous substances.
    2. Ensure footwear is clean and free from contaminants before entering the dispensing area.
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5.2 PPE Usage Guidelines

Follow these guidelines to ensure proper usage of PPE:

  1. Wearing PPE

    1. Ensure all required PPE is worn before entering the dispensing area. Verify that each item is properly fitted to ensure optimal protection.
    2. Ensure that PPE is worn at all times during the dispensing process, including during material handling, weighing, and transfer to mixing equipment.
  2. Inspection and Maintenance of PPE

    1. Inspect PPE regularly to ensure it is in good condition. Replace any damaged or worn-out PPE immediately to maintain a high level of protection.
    2. Dispose of single-use PPE in the appropriate waste containers immediately after use, and ensure that reusable items are cleaned and maintained according to SOPs.
  3. Training and Awareness

    1. Provide training to all personnel on the correct use of PPE, including how to properly wear, remove, and dispose of PPE to avoid contamination or injury.
    2. Conduct refresher training sessions regularly to ensure that PPE practices are consistently followed in the dispensing areas.
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5.3 PPE Compliance Monitoring

Ensure that all personnel comply with PPE requirements:

  1. Monitoring Compliance

    1. The QA team will regularly observe the use of PPE in dispensing areas to ensure compliance with SOPs.
    2. Non-compliance will be documented, and corrective actions will be taken, which may include retraining, disciplinary action, or additional oversight.
  2. Auditing PPE Usage

    1. Conduct periodic audits of PPE usage in dispensing areas to ensure adherence to safety protocols and identify areas for improvement.
    2. Document audit findings and take corrective actions as necessary to improve PPE compliance and safety practices.

5.4 Disposal of PPE

Ensure that used PPE is disposed of properly to maintain a safe and hygienic work environment:

  1. Disposal of Disposable PPE

    1. Dispose of used disposable PPE such as gloves, masks, and gowns in the designated biohazard or waste disposal containers immediately after use.
    2. Ensure that all disposal containers are clearly labeled and emptied regularly to prevent overflow or contamination.
  2. Cleaning and Maintenance of Reusable PPE

    1. Reusable PPE such as goggles, face shields, and lab coats should be cleaned and sanitized according to established cleaning procedures after each use.
    2. Inspect reusable PPE for any signs of damage or wear before each use and ensure that it is in good condition for continued use.
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5.5 Record-Keeping and Documentation

Maintain records of PPE usage, inspections, and training:

  1. Training Records

    1. Maintain records of all PPE training sessions, including dates, personnel trained, and the topics covered.
    2. Ensure that training records are kept for the required duration and are available for inspection by auditors or regulatory agencies.
  2. PPE Inspections and Audits

    1. Document all inspections and audits related to PPE compliance, including the findings, corrective actions taken, and any follow-up actions required.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • QC: Quality Control
  • PPE: Personal Protective Equipment

7. Documents

  1. Material Dispensing Log (Annexure-1)
  2. Training Records (Annexure-2)
  3. PPE Inspection and Audit Log (Annexure-3)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
  • EU GMP Guidelines Part I – Basic Requirements for Medicinal Products

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Material Dispensing Log

Date Material Name Batch Number Quantity Dispensed Dispensed By
03/02/2025 Excipient-123 Batch 56789 200 g John Doe

Annexure-2: Training Records

Date Personnel Name Training Topic Trainer Name
02/02/2025 John Doe PPE Usage and Compliance Jane Smith

Annexure-3: PPE Inspection and Audit Log

Date Inspection/Audit Type Findings Corrective Actions
03/02/2025 PPE Compliance Audit All PPE items in good condition No corrective actions required

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 PPE usage and monitoring procedures Standardization QA Head
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