Standard Operating Procedure for Personnel Hygiene and Gowning in Otic Manufacturing Unit
1) Purpose
To ensure that personnel maintain high standards of hygiene and gowning practices to prevent contamination during manufacturing of Otic (Ear) Dosage Forms.
2) Scope
This SOP applies to all personnel entering manufacturing areas where Otic dosage forms are processed, including production, quality control, and maintenance staff.
3) Responsibilities
Operators: Responsible for following gowning procedures and maintaining personal hygiene.
Supervisors: Responsible for ensuring compliance with gowning requirements.
Quality Assurance: Responsible for monitoring and auditing gowning practices.
4) Procedure
4.1 General Hygiene Requirements
4.1.1 Hand Washing
4.1.1.1 Wash hands thoroughly with soap and water before entering production areas.
4.1.1.2 Use hand sanitizers as per defined protocols.
4.1.2 Personal Protective Equipment (PPE)
4.1.2.1 Wear appropriate PPE including clean uniforms, hairnets, masks, and gloves.
4.1.2.2 Change PPE as required or when contamination is suspected.
4.2 Gowning Procedure
4.2.1 Gowning Area
4.2.1.1 Enter the designated gowning area.
4.2.1.2 Ensure the gowning area is clean and free from contaminants.
4.2.2 Gowning Steps
4.2.2.1 Don gown in the following order: coveralls, hair covers, face masks, and shoe covers.
4.2.2.2 Ensure all gowning steps are followed meticulously to prevent contamination.
4.3 Behavior in Manufacturing Areas
4.3.1 Conduct
4.3.1.1 Avoid unnecessary movements and activities that may compromise hygiene.
4.3.1.2 Report any breaches in hygiene practices immediately to supervisors.
5) Abbreviations, if any
PPE: Personal Protective Equipment
SOP: Standard Operating Procedure
6) Documents, if any
Gowning log
Training records for hygiene practices
7) Reference, if any
GMP guidelines for personnel hygiene in pharmaceutical manufacturing
8) SOP Version
Version 1.0
