stored safely. The QA Manager ensures overall compliance with safety and regulatory protocols.

5. Procedure

5.1 Safety Precautions

1. Personal Protective Equipment (PPE):
   • All personnel must wear flame-resistant lab coats, chemical-resistant gloves, safety goggles, and face shields.
   • Respirators must be used when handling highly volatile solvents.
2. Sampling Environment:
   • Perform sampling in designated explosion-proof, well-ventilated areas equipped with fume hoods.
   • Ensure no ignition sources (open flames, electrical sparks) are present in the sampling area.
   • Keep fire extinguishers and spill kits readily accessible.

5.2 Preparation for Sampling

1. Verification of Material:
   • Confirm the material’s identity, batch number, and storage conditions from the quarantine log.
   • Ensure the container is intact with no visible leaks or damage.
2. Equipment Preparation:
   • Use only grounded, spark-proof tools and containers for sampling.
   • Sterilize and dry all sampling equipment to prevent contamination.
   • Document equipment cleaning and preparation in the Equipment Preparation Log (Annexure-1).

5.3 Sampling Procedure

1. Opening the Container:
   • Carefully open the container in the fume hood to minimize vapor exposure.
   • Ground the container and sampling tools to prevent static discharge.
2. Sample Collection:
   • Use spark-proof pipettes or sampling bottles to withdraw the required sample volume.
   • Transfer the sample to pre-labeled, airtight containers designed for flammable substances.
   • Ensure containers are sealed immediately after sampling to prevent evaporation.
3. Labeling and Documentation:
   • Label each sample with Material Name, Batch Number, Date of Sampling, and Sampler’s Name.
   • Record all sampling details in the Solvent Sampling Log (Annexure-2).

5.4 Post-Sampling Procedures

1. Container Closure:
   • Ensure the original container is resealed tightly and returned to its designated storage location.
   • Document the closure and return of materials in the Storage Log (Annexure-3).
2. Sample Transport to QC Lab:
   • Transport samples in flame-resistant carriers to the QC lab.
   • Ensure temperature-sensitive solvents are transported under specified conditions.

5.5 Handling Deviations in Sampling

1. Deviation Reporting:
   • Report any spills, exposure incidents, or deviations in the sampling process to the QA Manager immediately.
   • Document deviations in the Sampling Deviation Report (Annexure-4).
2. Corrective Actions:
   • Investigate the root cause of deviations and implement corrective actions to prevent recurrence.
   • Document corrective measures in the Corrective Action Log (Annexure-5).

5.6 Training and Compliance

1. Personnel Training:
   • All personnel involved in sampling solvents and flammable materials must be trained in fire safety and handling procedures.
   • Document training completion in the Training Log (Annexure-6).
2. Compliance Monitoring:
   • QA must conduct regular audits to ensure adherence to safety and sampling protocols.
   • Document audit findings in the Compliance Audit Log (Annexure-7).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• PPE: Personal Protective Equipment

7. Documents

1. Equipment Preparation Log (Annexure-1)
2. Solvent Sampling Log (Annexure-2)
3. Storage Log (Annexure-3)
4. Sampling Deviation Report (Annexure-4)
5. Corrective Action Log (Annexure-5)
6. Training Log (Annexure-6)
7. Compliance Audit Log (Annexure-7)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• OSHA Standards for Handling Flammable and Combustible Liquids

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Equipment Preparation Log

Date	Equipment Name	Cleaning Method	Prepared By	Verified By (QA)
01/02/2025	Spark-Proof Pipette	Sterilization and Drying	Ravi Kumar	Anjali Mehta

Annexure-2: Solvent Sampling Log

Date	Material Name	Batch Number	Sample Volume	Sampled By	Verified By (QA)
01/02/2025	Ethanol	ET-2025-001	500 ml	Sunita Sharma	Ajay Singh

Annexure-3: Storage Log

Date	Material Name	Batch Number	Storage Location	Stored By
01/02/2025	Ethanol	ET-2025-001	Flammable Storage Cabinet A	Ravi Kumar

Annexure-4: Sampling Deviation Report

Date	Material Name	Batch Number	Deviation Description	Reported By
02/02/2025	Acetone	AC-2025-002	Container Leak Detected During Sampling	Ajay Singh

Annexure-5: Corrective Action Log

Date	Deviation Description	Corrective Action	Implemented By	Verified By (QA)
03/02/2025	Container Leak	Replaced Damaged Container and Inspected Storage Area	Ravi Kumar	Anjali Mehta

Annexure-6: Training Log

Date	Training Topic	Trainer	Attendee Name	Signature
04/02/2025	Safe Handling of Flammable Materials	Health & Safety Officer	Sunita Sharma

Annexure-7: Compliance Audit Log

Date	Audit Type	Findings	Corrective Actions Taken	Audited By
05/02/2025	Flammable Material Handling Compliance	Improper Labeling Detected	Revised Labeling Procedures	Anjali Mehta

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Updated Sampling and Safety Protocols for Flammable Materials	Regulatory Compliance	QA Head