Standard Operating Procedure for Personnel Hygiene and Gowning in Vaginal Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish guidelines for maintaining personnel hygiene and gowning practices to prevent contamination during the manufacturing of vaginal dosage forms.

2) Scope

This SOP applies to all personnel entering manufacturing areas involved in the production of vaginal dosage forms at [Company Name].

3) Responsibilities

Quality Assurance (QA) is responsible for ensuring compliance with gowning and hygiene practices. Production supervisors are responsible for monitoring and enforcing these practices.

4) Procedure

4.1 Hygiene Requirements

1. All personnel must maintain good personal hygiene including clean hands, hair, and nails.
2. Wash hands thoroughly with appropriate sanitizers or soaps before entering the production area.

4.2 Gowning Procedures

1. Wear designated cleanroom garments including gowns, caps, masks, and gloves according to the gowning procedure specified.
2. Inspect gowning apparel for cleanliness and integrity before use.

4.3 Change Room Protocol

1. Enter designated change rooms and follow the gowning sequence outlined.
2. Avoid unnecessary movements and ensure minimal exposure to external contaminants.

4.4 Restricted Access

1. Access to manufacturing areas is restricted to authorized personnel only.
2. Monitor entry and exit to minimize contamination risks.

4.5 Hygiene Practices During Work

1. Avoid touching face, hair, or any exposed skin areas during work.
2. Report any signs of illness or contamination immediately to supervisors.

5) Abbreviations, if any

QA: Quality Assurance; SOP: Standard Operating Procedure

6) Documents, if any

Gowning procedure document, Change room protocol

7) Reference, if any

USP Chapter 1240: “Personnel Practices,” WHO Technical Report Series No. 961, Annex 6: WHO good manufacturing practices for sterile pharmaceutical products

8) SOP Version

Version 1.0