Demand of pharmaceutical facility functionality: Validation and qualification of HVAC system
Main Article Content
Abstract
pharmaceutical facility functionality. The system is needed for maintenance of a suitable temperature, for continuous flow
of air, which ultimately prevents cross‑contamination and accumulation of air and to ensure the cooling of air in the premises.
The three core facets of HVAC system validation comprises of installation qualification (IQ), operational qualification (OQ), and
performance qualification (PQ). Validation of HVAC system is an essential subject to provide documented evidence about the
accuracy of results produced by it. The validation of HVAC system involves systemized and assembled documents of functional specifications; design drawings, plans, and specifications; validation master plan; testing, adjusting, and balancing (TAB); and startup reports. The various parameters to be evaluated for the validation of HVAC system include air flow pattern, air flow velocity, air changes per hour, filter leak test, particle count, viable monitoring, filter integrity test, pressure difference, recovery test for temperature and humidity, temperature and humidity uniformity, and fresh air determination.
Key words: Heating, qualification, validation, ventilation and air conditioning
Downloads
Article Details
This is an Open Access article distributed under the terms of the Attribution-Noncommercial 4.0 International License [CC BY-NC 4.0], which requires that reusers give credit to the creator. It allows reusers to distribute, remix, adapt, and build upon the material in any medium or format, for noncommercial purposes only.
References
Quality Assurance of Pharmaceuticals, A Compendium of Guidelines
and Related Materials. 2nd ed., Vol. 2. 2007.
Guideline on General Principles of Process Validation, May 1987,
FDA, CDRH/CDER.
Potdar MA. Pharmaceutical Quality Assurance, Nirali Prakashan, Pune,
Edition II, 2012.
FDA/Global Harmonization Task Force (GHTF; medical devices), Quality
Management Systems-Process Validation. 2nd ed. Guidance; 2004.
Guidance for Industry, Process Validation: General Principles and
Practices, U.S. Department of Health and Human Services, Food and
Drug Administration, Center for Drug Evaluation and Research (CDER),
Center for Biologics Evaluation and Research (CBER), Center for
Veterinary Medicine (CVM), January 2011, Current Good Manufacturing
Practices (CGMP), Revision 1.
FDA, Center for Drug Evaluation and Research (CDER), Center for
Biologics Evaluation and Research (CBER), Center for Veterinary
Medicine (CVM), Quality Systems Approach to Pharmaceutical Current
Good Manufacturing Practice Regulations, guidance for industry; 2006.
Guidance for Industry, Sterile Drug Products Produced by Aseptic
Processing–Current Good Manufacturing Practice, U.S. Department
of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER) Center for Biologics
Evaluation and Research (CBER) Office of Regulatory Affairs (ORA),
Pharmaceutical CGMPs; 2004.
Guidelines for the Validation of Chemical Methods for the FDA Foods
Program, Department of Health and Human Services, Public Health
Service Food And Drug Administration; 2012.
Scott B, Hargroves J, Bauers J. Validation of HVAC systems in
pharmaceutical and biotechnology facilities-Part 1.
Goldschmidt N. First steps for sustainable bio/pharma HVAC; 2009.
Shukla A, Katole A, Jain N, Karthikeyan C, Mehta F, Trivedi P. Risk
assessment approach: Qualification of a HVAC System in aseptic
processing area using building management system.
Guidance on Qualification of existing facilities, systems, equipment and
utilities, Active Pharmaceutical Ingredients Committee; 2004. p. 1‑16.
Supplementary guidelines on good manufacturing practices for heating,
ventilation and air‑conditioning systems for non‑sterile pharmaceutical
dosage forms. WHO Expert Committee on Specifications for
Pharmaceutical Preparations. Fortieth report. Geneva, World Health
Organization, 2006, Annexure 4 (WHO Technical Report Series, No. 937).
Supplementary guidelines on good manufacturing practices for heating,
ventilation and air‑conditioning systems for non‑sterile pharmaceutical
dosage forms. WHO Expert Committee on Specifications for
Pharmaceutical Preparations. 40th report. Geneva: World Health
Organization; 2011. Annexure 5 (WHO Technical Report Series, No. 961).
Guidance for Industry, Q7A Good Manufacturing, Practice Guidance
for Active Pharmaceutical Ingredients, U.S. Department of Health
and Human Services Food and Drug Administration, Center for Drug
Evaluation and Research (CDER) Center for Biologics Evaluation and
Research (CBER); 2001.