Demand of pharmaceutical facility functionality: Validation and qualification of HVAC system

Main Article Content

Anamika Singh
Sapna Malviya
Anil Kharia

Abstract

Heating, ventilation, and air system encompasses heating, ventilation, and air conditioning, which is integral component of
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

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How to Cite
Singh, A., Malviya, S., & Kharia, A. (2014). Demand of pharmaceutical facility functionality: Validation and qualification of HVAC system. Asian Journal of Pharmaceutics (AJP), 8(2). https://doi.org/10.22377/ajp.v8i2.349
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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.