and in compliance with all regulatory requirements. The QA Manager is responsible for reviewing documentation and ensuring compliance with GMP standards.

5. Procedure

5.1 Identification and Classification

1. Material Identification:
   • Identify all toxic and carcinogenic raw materials using the Safety Data Sheet (SDS) provided by the supplier.
   • Label materials clearly with hazard symbols and risk phrases according to GHS (Globally Harmonized System) standards.
   • Document material classification in the Toxic Material Identification Log (Annexure-1).

5.2 Handling Procedures

1. Personal Protective Equipment (PPE):
   • All personnel must wear appropriate PPE, including gloves, respirators, face shields, and chemical-resistant clothing when handling toxic materials.
   • Ensure PPE is checked for damage before each use and replaced as necessary.
   • Record PPE issuance in the PPE Issuance Log (Annexure-2).
2. Safe Handling Practices:
   • Handle materials in designated, well-ventilated areas or under fume hoods.
   • Avoid spills and ensure that containers are sealed tightly when not in use.
   • Document handling activities in the Toxic Material Handling Log (Annexure-3).

5.3 Storage Requirements

1. Designated Storage Areas:
   • Store toxic and carcinogenic materials in dedicated, clearly marked areas with restricted access.
   • Ensure that storage areas are equipped with proper ventilation and are compliant with regulatory standards.
   • Document storage conditions in the Toxic Material Storage Log (Annexure-4).

5.4 Spill and Exposure Management

1. Emergency Procedures for Spills:
   • In the event of a spill, evacuate the area and follow the emergency response protocol as outlined in the Safety Data Sheet (SDS).
   • Use spill containment kits and ensure proper disposal of contaminated materials.
   • Document spill incidents in the Spill Incident Log (Annexure-5).
2. Exposure Management:
   • If exposure occurs, provide immediate first aid and seek medical attention as necessary.
   • Report exposure incidents to the Safety Officer and document in the Exposure Incident Log (Annexure-6).

5.5 Documentation and Review

1. Record-Keeping Requirements:
   • Maintain all records related to toxic material handling, storage, and safety incidents for a minimum of five years.
   • Ensure all records are available for regulatory inspections and internal audits.
   • Document record retention details in the Record Retention Log (Annexure-7).
2. Review and Continuous Improvement:
   • QA and Safety Officers shall review safety protocols quarterly and recommend improvements if necessary.
   • Document reviews in the Safety Procedure Review Log (Annexure-8).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SDS: Safety Data Sheet
• PPE: Personal Protective Equipment
• GHS: Globally Harmonized System of Classification and Labeling of Chemicals

7. Documents

1. Toxic Material Identification Log (Annexure-1)
2. PPE Issuance Log (Annexure-2)
3. Toxic Material Handling Log (Annexure-3)
4. Toxic Material Storage Log (Annexure-4)
5. Spill Incident Log (Annexure-5)
6. Exposure Incident Log (Annexure-6)
7. Record Retention Log (Annexure-7)
8. Safety Procedure Review Log (Annexure-8)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• OSHA Hazard Communication Standard (29 CFR 1910.1200)
• WHO GMP Guidelines
• Globally Harmonized System of Classification and Labeling of Chemicals (GHS)

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Toxic Material Identification Log

Date	Material Name	Classification (Toxic/Carcinogenic)	Batch Number	Identified By
09/03/2025	Benzene	Carcinogenic	BNZ-4567	Ravi Kumar

Annexure-2: PPE Issuance Log

Date	Employee Name	PPE Type Issued	Quantity	Issued By	Remarks
09/03/2025	Neha Verma	Respirator Mask, Nitrile Gloves	1 Set	Ravi Kumar	For handling Benzene
09/03/2025	Amit Joshi	Chemical-Resistant Suit, Face Shield	1 Set	Priya Singh	For solvent transfer operation

Annexure-3: Toxic Material Handling Log

Date	Material Name	Batch Number	Handling Procedure	Handled By	Verified By
09/03/2025	Benzene	BNZ-4567	Transferred to storage under fume hood	Neha Verma	Ravi Kumar
09/03/2025	Formaldehyde	FRM-7890	Sealed in airtight containers after sampling	Amit Joshi	Priya Singh

Annexure-4: Toxic Material Storage Log

Date	Material Name	Batch Number	Storage Location	Temperature (°C)	Stored By
09/03/2025	Benzene	BNZ-4567	Toxic Material Cabinet A1	20°C	Ravi Kumar
09/03/2025	Formaldehyde	FRM-7890	Ventilated Storage Room B3	18°C	Neha Verma

Annexure-5: Spill Incident Log

Date	Material Name	Batch Number	Spill Description	Action Taken	Reported By
09/03/2025	Formaldehyde	FRM-7890	Minor spill during transfer	Evacuated area, neutralized, and disposed	Amit Joshi
09/03/2025	Benzene	BNZ-4567	Container leakage detected	Sealed leak, moved to quarantine	Neha Verma

Annexure-6: Exposure Incident Log

Date	Employee Name	Material Exposed To	Exposure Description	First Aid Provided	Reported By
09/03/2025	Ravi Kumar	Formaldehyde	Inhalation during spill cleanup	Moved to fresh air, medical attention provided	Amit Joshi
09/03/2025	Neha Verma	Benzene	Skin contact while handling	Washed area with soap and water	Priya Singh

Annexure-7: Record Retention Log

Date	Document Name	Retention Period	Stored By	Storage Location
09/03/2025	Toxic Material Handling Log	5 Years	Priya Singh (QA)	Document Control Room A
09/03/2025	Spill Incident Log	5 Years	Rajeev Menon (QA)	Document Control Room B

Annexure-8: Safety Procedure Review Log

Date	Review Type	Findings	Recommendations	Reviewed By
09/03/2025	Quarterly Review	Increased spill incidents during material transfer	Implement additional spill training sessions	Priya Singh (QA)
09/03/2025	Annual Review	PPE compliance satisfactory, minor issues with storage labeling	Standardize labeling procedures	Rajeev Menon (QA)

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
09/03/2025	2.0	Updated handling protocols and PPE requirements	Alignment with updated GMP and OSHA standards	QA Head