Ointments: SOP for Dispensing High-Potency Active Pharmaceutical Ingredients (HPAPIs) – V 2.0

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SOP for Dispensing High-Potency Active Pharmaceutical Ingredients (HPAPIs) – V 2.0

Procedure for Dispensing High-Potency Active Pharmaceutical Ingredients (HPAPIs)

Department Production/Quality Assurance (QA)/Quality Control (QC)/Safety
SOP No. SOP/Ointment/172
Supersedes V 1.0
Page No. Page X of Y
Issue Date [Insert Issue Date]
Effective Date [Insert Effective Date]
Review Date [Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a controlled and safe method for handling and dispensing High-Potency Active Pharmaceutical Ingredients (HPAPIs). This SOP ensures worker safety, prevents contamination, and maintains compliance with GMP, OSHA, and regulatory guidelines.

2. Scope

This SOP applies to all personnel involved in the dispensing, weighing, and handling of HPAPIs in the Production, Quality Assurance (QA), Quality Control (QC), and Safety departments.

3. Responsibilities

  • Dispensing Operator: Handles and dispenses HPAPIs following containment protocols.
  • QA Officer: Ensures compliance with safety, quality, and regulatory standards.
  • QC Analyst: Conducts sampling and quality verification.
  • Safety Officer: Implements exposure monitoring and emergency procedures.
  • Production Supervisor: Oversees dispensing operations and ensures protocol adherence.
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4. Accountability

The QA Manager and Safety Officer are accountable for ensuring that all HPAPI handling activities comply with GMP, OSHA, FDA, ICH, and WHO regulations.

5. Procedure

5.1 Classification of HPAPIs

HPAPIs are categorized based on their Occupational Exposure Limit (OEL):

  • OEL 1: Low potency, minimal handling precautions required.
  • OEL 2: Moderate potency, requires basic containment measures.
  • OEL 3: High potency, requires restricted access and closed handling systems.
  • OEL 4: Extremely potent, requires full containment and personal protective equipment (PPE).

5.2 Personal Protective Equipment (PPE) Requirements

All personnel handling HPAPIs must wear:

  • Double-layer nitrile gloves.
  • Full-body protective coveralls.
  • Powered air-purifying respirators (PAPR) for OEL 3 and 4 HPAPIs.
  • Safety goggles or full-face shields.
  • Antistatic footwear.

5.3 Environmental Controls for HPAPI Dispensing

  • Dispensing must be performed in **isolators, closed restricted access barrier systems (RABS), or dedicated containment booths.**
  • High-efficiency particulate air (HEPA) filtration must be used in all containment areas.
  • Dispensing areas must have **negative pressure** relative to surrounding areas.
  • Solvent-based HPAPI handling must be conducted in **explosion-proof environments.**
  • Temperature and humidity levels must be maintained as per stability guidelines.
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5.4 HPAPI Dispensing Process

  • Only **authorized personnel** are permitted to dispense HPAPIs.
  • Before dispensing:
    • Verify batch number, identity, and expiry date.
    • Ensure containment system integrity.
    • Confirm that emergency spill kits and safety equipment are available.
  • During dispensing:
    • Use **closed transfer systems** to minimize airborne contamination.
    • Weigh and dispense HPAPIs in **pre-approved quantities only.**
    • Minimize dust generation by using **pre-wetted techniques if applicable.**
  • After dispensing:
    • Immediately seal all HPAPI containers.
    • Dispose of waste in **designated hazardous waste bins.**
    • Record all activities in the **HPAPI Dispensing Log (Annexure-1).**

6. Abbreviations

  • GMP – Good Manufacturing Practices
  • QA – Quality Assurance
  • QC – Quality Control
  • HPAPI – High-Potency Active Pharmaceutical Ingredient
  • OEL – Occupational Exposure Limit
  • RABS – Restricted Access Barrier System
  • HEPA – High-Efficiency Particulate Air
  • OSHA – Occupational Safety and Health Administration
  • FDA – Food and Drug Administration
  • ICH – International Council for Harmonisation
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7. Documents

  • HPAPI Dispensing Log (Annexure-1)
  • HPAPI Incident Report Log (Annexure-2)

8. References

  • ICH Q7 – GMP for Active Pharmaceutical Ingredients
  • WHO Guidelines on Safe Handling of HPAPIs
  • OSHA Standards on Exposure Limits

9. SOP Version

Version 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: HPAPI Dispensing Log

Date HPAPI Name Batch No. Quantity Dispensed Operator QA Review
02/02/2025 Cytotoxic Compound HP-1001 2.5g John Doe Approved

12. Revision History

Revision Date Revision No. Details Reason Approved By
02/02/2025 2.0 Expanded HPAPI Handling Procedures Improved Safety Compliance QA Head
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