Standard Operating Procedure for Maintenance of Personal Protective Equipment (PPE)

1) Purpose

The purpose of this SOP is to establish the procedures for the maintenance and care of personal protective equipment (PPE) to ensure effectiveness and safety for personnel in pharmaceutical manufacturing facilities.

2) Scope

This SOP applies to all types of personal protective equipment (PPE) used by personnel in pharmaceutical manufacturing facilities, including but not limited to gloves, masks, goggles, respirators, and protective clothing.

3) Responsibilities

The Facility Management Department is responsible for implementing and adhering to this SOP. The Safety Officer is responsible for overseeing compliance and ensuring proper maintenance of PPE.

4) Procedure

1. Inspection and Cleaning
   1. Inspect PPE before each use for damage, wear, or contamination.
   2. Clean PPE according to manufacturer guidelines and facility protocols.
   3. Replace PPE that cannot be adequately cleaned or has reached the end of its service life.
2. Storage
   1. Store PPE in designated areas that are clean, dry, and protected from environmental hazards.
   2. Ensure PPE is stored in a manner that maintains its shape and integrity.
   3. Regularly inspect storage areas for cleanliness and organization.
3. Training
   1. Provide training to personnel on the proper use, care, and maintenance of PPE.
   2. Ensure personnel understand when and how to replace PPE.
4. Record Keeping
   1. Maintain records of PPE inspections, cleaning, replacements, and training sessions.
   2. Document any issues identified during inspections and actions taken.
   3. Archive records for future reference and regulatory inspections.

5) Abbreviations, if any

PPE: Personal Protective Equipment

6) Documents, if any

Inspection Records, Cleaning Procedures, Training Logs, PPE Manufacturer Guidelines

7) Reference, if any

Relevant regulatory guidelines such as FDA, EMA, and WHO GMP requirements for maintenance and use of personal protective equipment in pharmaceutical manufacturing facilities.

8) SOP Version

Version 1.0