Guidelines for HVAC System Validation in Vaginal Dosage Form Manufacturing
1) Purpose
The purpose of this SOP is to establish procedures for the validation of HVAC (Heating, Ventilation, and Air Conditioning) systems used in the manufacturing of vaginal dosage forms to ensure controlled environmental conditions.
2) Scope
This SOP applies to all HVAC 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 HVAC system validation activities are conducted in compliance with this SOP.
4) Procedure
4.1 HVAC System Design Qualification (DQ)
- Review and approve HVAC system design specifications to ensure they meet regulatory and operational requirements.
- Verify that the HVAC design includes adequate capacity for temperature and humidity control as per product requirements.
4.2 Installation Qualification (IQ)
- Verify that HVAC equipment is installed correctly and according to approved design specifications.
- Check and record installation details such as ductwork, filters, sensors, and control systems.
4.3 Operational Qualification (OQ)
- Test HVAC system under operational conditions to ensure it functions as intended.
- Verify temperature and humidity control through performance testing and calibration of sensors.
4.4 Performance Qualification (PQ)
- Validate HVAC system performance over a defined period to ensure consistent environmental conditions.
- Monitor and record temperature and humidity levels during routine operations.
5) Abbreviations, if any
N/A
6) Documents, if any
HVAC system design specifications, IQ/OQ/PQ protocols, Calibration records
7) Reference, if any
ICH Q9 Quality Risk Management, EU GMP Annex 1: Manufacture of Sterile Medicinal Products, FDA Guidance for Industry: HVAC Systems in Pharmaceutical Facilities
8) SOP Version
Version 1.0
