ensuring compliance with GMP and regulatory standards through documentation review and audits.

5. Procedure

5.1 Identification and Classification of HPAPIs

1. Initial Identification:
   • Identify HPAPIs based on supplier-provided Safety Data Sheets (SDS) and classification criteria.
   • Label HPAPIs with appropriate hazard symbols and ensure classification is updated regularly.
   • Record the identification details in the HPAPI Identification Log (Annexure-1).

5.2 Storage Requirements

1. Designated Storage Areas:
   • Store HPAPIs in segregated, secure, and well-ventilated areas with controlled access.
   • Ensure proper containment using double-sealed packaging and storage within dedicated cabinets or rooms.
   • Document storage details in the HPAPI Storage Log (Annexure-2).
2. Environmental Controls:
   • Maintain specified temperature and humidity conditions as per SDS recommendations.
   • Monitor environmental parameters continuously and document in the Environmental Monitoring Log (Annexure-3).

5.3 Handling Procedures

1. Personal Protective Equipment (PPE):
   • Ensure all personnel handling HPAPIs wear appropriate PPE, including respirators, gloves, and protective clothing.
   • Record PPE issuance and compliance in the PPE Compliance Log (Annexure-4).
2. Safe Handling Practices:
   • Use closed systems or containment devices when transferring or sampling HPAPIs.
   • Avoid direct contact with HPAPIs and minimize exposure by following strict handling protocols.
   • Document handling activities in the HPAPI Handling Log (Annexure-5).

5.4 Spill and Exposure Management

1. Spill Containment:
   • In case of spills, evacuate the area, use spill containment kits, and follow the emergency response procedure as outlined in the SDS.
   • Dispose of contaminated materials as per hazardous waste disposal guidelines.
   • Document spill incidents in the Spill Incident Log (Annexure-6).
2. Exposure Response:
   • Immediately report any exposure to HPAPIs, administer first aid, and seek medical attention as required.
   • Record exposure incidents in the Exposure Incident Log (Annexure-7).

5.5 Documentation and Review

1. Record-Keeping Requirements:
   • Maintain all records related to HPAPI storage, handling, and safety incidents for at least five years.
   • Ensure records are readily accessible for audits and regulatory inspections.
   • Document record retention in the Record Retention Log (Annexure-8).
2. Review and Continuous Improvement:
   • Conduct quarterly reviews of HPAPI handling procedures and storage conditions.
   • Document review outcomes and suggested improvements in the Management Review Log (Annexure-9).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SDS: Safety Data Sheet
• PPE: Personal Protective Equipment
• HPAPI: Highly Potent Active Pharmaceutical Ingredient

7. Documents

1. HPAPI Identification Log (Annexure-1)
2. HPAPI Storage Log (Annexure-2)
3. Environmental Monitoring Log (Annexure-3)
4. PPE Compliance Log (Annexure-4)
5. HPAPI Handling Log (Annexure-5)
6. Spill Incident Log (Annexure-6)
7. Exposure Incident Log (Annexure-7)
8. Record Retention Log (Annexure-8)
9. Management Review Log (Annexure-9)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• OSHA Hazard Communication Standard (29 CFR 1910.1200)
• WHO 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: HPAPI Identification Log

Date	HPAPI Name	Classification (Toxic/Highly Potent)	Batch Number	Identified By
11/03/2025	Cytarabine	Highly Potent	CYT-2345	Ravi Kumar

Annexure-2: HPAPI Storage Log

Date	HPAPI Name	Batch Number	Storage Location	Storage Conditions	Stored By
11/03/2025	Cytarabine	CYT-2345	HPAPI Storage Cabinet A1	Temperature: 2-8°C, Humidity: <50%	Ravi Kumar
11/03/2025	Paclitaxel	PCL-6789	Controlled Access Room B2	Temperature: 20-25°C, Ventilated	Neha Verma

Annexure-3: Environmental Monitoring Log

Date	Storage Location	Temperature (°C)	Humidity (%)	Status	Checked By
11/03/2025	HPAPI Storage Cabinet A1	4°C	45%	Within Limits	Amit Joshi
11/03/2025	Controlled Access Room B2	23°C	48%	Within Limits	Priya Singh

Annexure-4: PPE Compliance Log

Date	Employee Name	HPAPI Handled	PPE Used	Compliance Status	Checked By
11/03/2025	Neha Verma	Cytarabine	Respirator, Gloves, Safety Goggles	Compliant	Ravi Kumar
11/03/2025	Amit Joshi	Paclitaxel	Protective Suit, Face Shield, Gloves	Compliant	Priya Singh

Annexure-5: HPAPI Handling Log

Date	HPAPI Name	Batch Number	Handling Procedure	Handled By	Verified By
11/03/2025	Cytarabine	CYT-2345	Transferred to cleanroom under containment hood	Neha Verma	Ravi Kumar
11/03/2025	Paclitaxel	PCL-6789	Sampled for QC testing under fume hood	Amit Joshi	Priya Singh

Annexure-6: Spill Incident Log

Date	HPAPI Name	Batch Number	Spill Description	Action Taken	Reported By
11/03/2025	Paclitaxel	PCL-6789	Minor spill during sampling	Evacuated area, cleaned with spill kit, disposed of waste	Amit Joshi
11/03/2025	Cytarabine	CYT-2345	Container leakage detected	Contained leak, transferred to quarantine area	Neha Verma

Annexure-7: Exposure Incident Log

Date	Employee Name	HPAPI Exposed To	Exposure Description	First Aid Provided	Reported By
11/03/2025	Ravi Kumar	Cytarabine	Skin contact during transfer	Area washed thoroughly, no further symptoms observed	Neha Verma
11/03/2025	Amit Joshi	Paclitaxel	Inhalation exposure due to mask malfunction	Moved to fresh air, medical attention provided	Priya Singh

Annexure-8: Record Retention Log

Date	Document Name	Retention Period	Stored By	Storage Location
11/03/2025	HPAPI Handling Log	5 Years	Priya Singh (QA)	Document Control Room A
11/03/2025	Spill Incident Log	5 Years	Ravi Kumar	Document Control Room B

Annexure-9: Management Review Log

Date	Review Type	Findings	Recommendations	Reviewed By
11/03/2025	Quarterly Review	Increased spill incidents during HPAPI handling	Enhance staff training and improve containment equipment	Priya Singh (QA)
11/03/2025	Annual Review	Environmental controls effective, minor PPE compliance issues	Implement stricter PPE checks and monitoring	Ravi Kumar

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Implementation	QA Head
11/03/2025	2.0	Updated HPAPI handling protocols and storage requirements	Compliance with revised GMP and safety guidelines	QA Head