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.
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.
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).**
5.5 Exposure Control and Monitoring
- Airborne exposure monitoring must be performed **weekly**.
- Surface contamination testing must be conducted **monthly**.
- Operators must undergo periodic **biological exposure monitoring.**
5.6 Emergency Procedures
- In case of HPAPI spills:
- Evacuate non-essential personnel.
- Contain the spill using absorbent pads.
- Dispose of contaminated materials as per hazardous waste protocols.
- In case of exposure:
- Skin contact: Immediately wash with soap and water.
- Eye contact: Rinse with water for at least **15 minutes** and seek medical attention.
- Inhalation: Move to fresh air and report to the medical officer.
5.7 Documentation and Record Keeping
- All HPAPI dispensing activities must be recorded in the **HPAPI Dispensing Log (Annexure-1).**
- Deviations and safety incidents must be documented in the **HPAPI Incident Report Log (Annexure-2).**
- Records must be maintained for **at least 7 years** and be accessible for audits.
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
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 |