Standard Operating Procedure for Operator Training on Solvent Safety in API Manufacturing

Department	API Manufacturing
SOP No.	SOP/API/055/2025
Supersedes	SOP/API/055/2022
Page No.	Page 1 of 10
Issue Date	13/04/2025
Effective Date	15/04/2025
Review Date	13/04/2026

1. Purpose

To provide a standardized framework for the training of API manufacturing operators on the safe handling, storage, and disposal of solvents to ensure personnel safety, process efficiency, and regulatory compliance.

2. Scope

This SOP applies to all production and maintenance personnel involved in the handling, storage, recovery, and disposal of solvents in API manufacturing.

3. Responsibilities

• Training Coordinator: Develop and update solvent safety training modules.
• EHS Officer: Deliver training and assess risk awareness.
• Departmental Supervisor: Nominate participants and track attendance.
• QA Department: Review training effectiveness and maintain records.

4. Accountability

The Head of Manufacturing is accountable for ensuring all relevant operators receive solvent safety training. The EHS Manager is responsible for the training content and delivery.

5. Procedure

5.1 Training Schedule and Nomination

1. Conduct solvent safety training:
   • During onboarding of new operators
   • Annually for existing personnel
   • After major solvent-related incidents or process changes
2. Supervisors shall submit nominations via the “Training Nomination Form” (Annexure-1).

5.2 Training Content

1. Topics to be covered:
   • Classification of solvents (flammable, toxic, reactive)
   • Labeling and storage guidelines
   • Use of PPE and safe handling procedures
   • Emergency response to spills and fire
   • First-aid measures for solvent exposure
   • MSDS interpretation
   • Waste segregation and disposal
2. Use a combination of classroom training, videos, demonstrations, and practical assessments.

5.3 Evaluation and Certification

1. Conduct a written and/or practical assessment post-training.
2. Minimum passing score: 75%
3. Issue “Solvent Safety Training Certificate” valid for one year (Annexure-2).

5.4 Record Keeping and Monitoring

1. Maintain a “Training Attendance and Assessment Record” (Annexure-3).
2. QA to verify training records during GMP audits and internal reviews.
3. Refresher training shall be scheduled if:
   • New solvent type is introduced
   • A fire/spill incident occurs
   • Regulatory guidelines are updated

6. Abbreviations

• SOP: Standard Operating Procedure
• PPE: Personal Protective Equipment
• EHS: Environment, Health and Safety
• MSDS: Material Safety Data Sheet
• QA: Quality Assurance

7. Documents

1. Training Nomination Form (Annexure-1)
2. Solvent Safety Training Certificate (Annexure-2)
3. Training Attendance and Assessment Record (Annexure-3)

8. References

• ICH Q9 – Quality Risk Management
• OSHA Standard 1910.1200 – Hazard Communication
• GMP Training Guidelines for Pharmaceutical Industry

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Training Nomination Form

Employee Name	Department	Designation	Training Date	Nominated By
Ravi Singh	Production	Operator	15/04/2025	Shift In-Charge

Annexure-2: Solvent Safety Training Certificate

This is to certify that [Employee Name] has successfully completed solvent safety training on [Date] and is authorized to handle solvents in the API manufacturing unit.

Annexure-3: Training Attendance and Assessment Record

Name	Department	Score (%)	Status	Trainer
Ravi Singh	Production	85	Passed	EHS Officer

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	Training System Implementation	QA Head
13/04/2025	2.0	Assessment Criteria and Certificate Format Added	Audit Observation	QA Head