Guidelines for Water System Validation in Vaginal Dosage Form Manufacturing
1) Purpose
The purpose of this SOP is to establish procedures for the validation of water systems used in the manufacturing of vaginal dosage forms to ensure the consistent production of high-quality water.
2) Scope
This SOP applies to all water systems within the pharmaceutical manufacturing facility involved in the production, storage, and testing of vaginal dosage forms.
3) Responsibilities
It is the responsibility of the Engineering and Quality Assurance departments to ensure that water system validation activities are conducted in compliance with this SOP.
4) Procedure
4.1 Water System Design Qualification (DQ)
- Review and approve water system design specifications to ensure they meet regulatory and operational requirements.
- Verify that the water system design includes adequate capacity and quality control measures as per product requirements.
4.2 Installation Qualification (IQ)
- Verify that water system equipment is installed correctly and according to approved design specifications.
- Check and record installation details such as piping, filters, tanks, and control systems.
4.3 Operational Qualification (OQ)
- Test the water system under operational conditions to ensure it functions as intended.
- Verify water quality parameters through performance testing and calibration of sensors.
4.4 Performance Qualification (PQ)
- Validate water system performance over a defined period to ensure consistent water quality.
- Monitor and record water quality parameters such as pH, conductivity, and microbial levels during routine operations.
5) Abbreviations, if any
N/A
6) Documents, if any
Water system design specifications, IQ/OQ/PQ protocols, Calibration records
7) Reference, if any
USP <1231> Water for Pharmaceutical Purposes, EU GMP Annex 1: Manufacture of Sterile Medicinal Products, FDA Guidance for Industry: Water for Pharmaceutical Use
8) SOP Version
Version 1.0
