ensuring compliance with GMP standards.

5. Procedure

5.1 Identification and Classification

1. Initial Identification:
   • Review the Safety Data Sheets (SDS) provided by the supplier to classify materials as high-risk based on toxicity, flammability, reactivity, or environmental hazards.
   • Label materials with hazard symbols according to the Globally Harmonized System (GHS) standards.
   • Document the classification in the High-Risk Material Identification Log (Annexure-1).
2. Periodic Review:
   • Review high-risk material classifications quarterly to ensure they meet current safety standards.
   • Update labels and documentation as necessary based on new safety information.

5.2 Storage and Handling Procedures

1. Designated Storage Areas:
   • Store high-risk materials in designated, clearly marked areas with restricted access.
   • Ensure that flammable and reactive materials are stored separately in compliance with safety guidelines.
   • Document storage conditions in the High-Risk Material Storage Log (Annexure-2).
2. Personal Protective Equipment (PPE):
   • Ensure all personnel handling high-risk materials are equipped with appropriate PPE, including gloves, goggles, and respirators.
   • Record PPE usage in the PPE Compliance Log (Annexure-3).

5.3 Risk Mitigation and Emergency Procedures

1. Risk Assessment:
   • Conduct risk assessments for all high-risk materials, identifying potential hazards and implementing control measures.
   • Document risk assessments in the Risk Assessment Log (Annexure-4).
2. Emergency Response:
   • Develop emergency procedures for handling spills, exposures, or fires involving high-risk materials.
   • Ensure all personnel are trained in emergency response protocols.
   • Document emergency drills and responses in the Emergency Response Log (Annexure-5).

5.4 Documentation and Review

1. Record-Keeping Requirements:
   • Maintain all records related to the identification, storage, and management of high-risk materials for a minimum of five years.
   • Ensure records are available for regulatory inspections and internal audits.
   • Document record retention in the Record Retention Log (Annexure-6).
2. Review and Continuous Improvement:
   • QA and Safety Officers shall review high-risk material management procedures quarterly and recommend improvements as needed.
   • Document review findings in the Management Review Log (Annexure-7).

6. Abbreviations

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

7. Documents

1. High-Risk Material Identification Log (Annexure-1)
2. High-Risk Material Storage Log (Annexure-2)
3. PPE Compliance Log (Annexure-3)
4. Risk Assessment Log (Annexure-4)
5. Emergency Response Log (Annexure-5)
6. Record Retention Log (Annexure-6)
7. Management Review Log (Annexure-7)

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: High-Risk Material Identification Log

Date	Material Name	Classification (Flammable/Toxic/Reactive)	Batch Number	Identified By
10/03/2025	Acetone	Flammable	ACT-1234	Ravi Kumar

Annexure-2: High-Risk Material Storage Log

Date	Material Name	Batch Number	Storage Location	Storage Conditions	Stored By
10/03/2025	Acetone	ACT-1234	Flammable Storage Cabinet A1	Temperature: 20°C, Ventilated	Ravi Kumar
10/03/2025	Hydrochloric Acid	HCL-5678	Corrosive Materials Room B3	Temperature: 22°C, Isolated from bases	Neha Verma

Annexure-3: PPE Compliance Log

Date	Employee Name	Material Handled	PPE Used	Compliance Status	Checked By
10/03/2025	Amit Joshi	Acetone	Gloves, Respirator, Safety Goggles	Compliant	Priya Singh
10/03/2025	Neha Verma	Hydrochloric Acid	Chemical-Resistant Apron, Gloves, Face Shield	Compliant	Ravi Kumar

Annexure-4: Risk Assessment Log

Date	Material Name	Risk Identified	Severity Level	Control Measures Implemented	Assessed By
10/03/2025	Acetone	Flammability risk near heat sources	High	Stored in flammable cabinet, away from ignition	Priya Singh
10/03/2025	Hydrochloric Acid	Corrosive risk to skin and eyes	Medium	Use of PPE and isolated storage	Ravi Kumar

Annexure-5: Emergency Response Log

Date	Emergency Type	Material Involved	Response Actions Taken	Outcome	Reported By
10/03/2025	Spill	Acetone	Evacuated area, used spill kit, ventilated room	Area cleared and material safely contained	Neha Verma
10/03/2025	Exposure	Hydrochloric Acid	Administered first aid, flushed skin with water	Minor injury, no further action required	Amit Joshi

Annexure-6: Record Retention Log

Date	Document Name	Retention Period	Stored By	Storage Location
10/03/2025	High-Risk Material Storage Log	5 Years	Priya Singh (QA)	Document Control Room A
10/03/2025	Emergency Response Log	5 Years	Ravi Kumar	Document Control Room B

Annexure-7: Management Review Log

Date	Review Type	Findings	Recommendations	Reviewed By
10/03/2025	Quarterly Review	Improper segregation of flammable and corrosive materials	Rearrange storage areas, reinforce training	Priya Singh (QA)
10/03/2025	Annual Review	PPE compliance satisfactory, minor labeling issues	Standardize hazard labeling procedures	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
10/03/2025	2.0	Updated risk management protocols and emergency procedures	Alignment with updated GMP and OSHA guidelines	QA Head