of API manufacturing where PPE is required. It covers types of PPE for general use and area-specific PPE such as for solvent handling, cleanrooms, and maintenance activities.

3. Responsibilities

• EHS Officer: Approves PPE types, ensures availability, and conducts training.
• Warehouse Team: Maintains PPE inventory and issues PPE based on request forms.
• Departmental Supervisors: Ensure compliance with PPE requirements during operations.
• All Personnel: Use issued PPE properly and report damage or discomfort immediately.

4. Accountability

The EHS Manager is accountable for the implementation of PPE policies, ensuring the correct use and adequacy of protective gear, and reviewing PPE effectiveness during internal safety audits.

5. Procedure

5.1 PPE Requirement Assessment

1. EHS shall conduct a Job Hazard Analysis (JHA) to determine PPE needs for each role and activity.
2. Annually review PPE requirements and update the PPE Matrix (Annexure-1).

5.2 Types of PPE Used

1. The following categories of PPE shall be maintained:
   • Head Protection – Safety helmet, bouffant cap
   • Eye and Face Protection – Safety goggles, face shields
   • Hand Protection – Nitrile gloves, heat-resistant gloves
   • Body Protection – Coveralls, lab coats
   • Respiratory Protection – N95 masks, respirators
   • Foot Protection – Safety shoes, antistatic footwear
   • Hearing Protection – Ear plugs, ear muffs (in high-noise areas)

5.3 PPE Distribution Procedure

1. Employees shall fill out the PPE Request Form (Annexure-2) during onboarding or when replacement is needed.
2. The warehouse team shall issue PPE and log it in the PPE Issuance Register (Annexure-3).
3. Department head or supervisor must verify and acknowledge receipt.

5.4 PPE Usage Guidelines

1. Personnel must:
   • Wear PPE before entering designated areas
   • Use PPE as per signage and operational requirement
   • Report damaged PPE to the supervisor immediately
2. Visual display boards shall indicate mandatory PPE in specific areas.

5.5 PPE Maintenance and Storage

1. Reusable PPE (e.g., face shields) shall be cleaned after each use and stored in labeled lockers.
2. Contaminated PPE shall be disposed of in hazardous bins as per SOP/API/203/2025.
3. PPE Storage Rooms must be clean, dry, and access-controlled.

5.6 PPE Replacement Criteria

1. Replacement shall occur under the following:
   • Physical damage or wear and tear
   • Contamination beyond cleaning
   • Exceeded expiry date
2. Record replacement in the PPE Replacement Log (Annexure-4).

5.7 Visitor and Contractor PPE

1. Visitors must be issued disposable PPE from the reception (recorded in Annexure-5).
2. Contractors working in hazardous areas shall follow the same PPE protocol as employees.

5.8 Training and Awareness

1. Initial PPE training shall be conducted for all new joiners.
2. Refresher sessions shall be held every 6 months or after safety incidents.
3. Training logs shall be recorded in the PPE Training Record Sheet (Annexure-6).

6. Abbreviations

• PPE: Personal Protective Equipment
• EHS: Environment, Health & Safety
• JHA: Job Hazard Analysis
• SOP: Standard Operating Procedure

7. Documents

1. PPE Matrix – Annexure-1
2. PPE Request Form – Annexure-2
3. PPE Issuance Register – Annexure-3
4. PPE Replacement Log – Annexure-4
5. Visitor PPE Log – Annexure-5
6. PPE Training Record Sheet – Annexure-6

8. References

• OSHA 1910 Subpart I – Personal Protective Equipment
• WHO GMP Guidelines – Personal Hygiene & Protective Measures
• ICH Q9 – Risk Management

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: PPE Matrix

Department	Activity	Required PPE
Production	Solvent Charging	Nitrile gloves, face shield, respirator
Maintenance	Welding	Goggles, heat gloves, helmet

Annexure-2: PPE Request Form

Name	Employee ID	PPE Requested	Reason	Date
Sunita Reddy	EMP0123	Safety Shoes	Damaged	13/04/2025

Annexure-3: PPE Issuance Register

Name	Department	PPE Issued	Date	Issued By
Rajesh Kumar	QA	Goggles, N95 mask	12/04/2025	Store Assistant

Annexure-4: PPE Replacement Log

Employee Name	PPE Replaced	Date	Reason	Approved By
Vijay Patil	Coverall	10/04/2025	Torn	Supervisor

Annexure-5: Visitor PPE Log

Visitor Name	Company	PPE Issued	Date	Returned
Dr. Meena Shah	FDA	Lab coat, cap	09/04/2025	Yes

Annexure-6: PPE Training Record Sheet

Employee	Department	Training Date	Trainer	Signature
Anil Mehra	Production	08/04/2025	EHS Officer

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial version	New SOP	QA Head
14/04/2025	2.0	Annexure additions and procedural clarifications	Audit Recommendation	QA Head