Authors :
Rathore Aakash; Singh Anamika; Malviya Sapna; Kharia Anil
Volume/Issue :
Volume 9 - 2024, Issue 7 - July
Google Scholar :
https://tinyurl.com/5dvdpskn
Scribd :
https://tinyurl.com/bddys6sk
DOI :
https://doi.org/10.38124/ijisrt/IJISRT24JUL1732
Note : A published paper may take 4-5 working days from the publication date to appear in PlumX Metrics, Semantic Scholar, and ResearchGate.
Abstract :
Heating, ventilation, and air conditioning
(HVAC) systems plays a critical role in pharmaceutical
manufacturing facilities by ensuring the integrity of
product quality, safety, and compliance with regulatory
requirements. HVAC validation is an essential process
that verifies and documents the performance and
effectiveness of these systems. This review paper explores
various strategies and approaches to HVAC validation in
pharmaceutical manufacturing facilities, including
regulatory considerations, validation methodologies, risk
assessment, and ongoing monitoring. The paper also
discusses the challenges associated with HVAC validation
and presents best practices to improve the effectiveness of
the validation process.
Keywords :
Heating, Ventilation, and Air Conditioning (HVAC), Validation.
References :
- Sharma, P. P. (Year). Validation in Pharmaceutical Industry: Concepts, Approaches & Guidelines (1st ed.). Vandana Publication Pvt. Ltd. (Pages 165-191).
- World Health Organization. (2006). Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials. Vol. 2 Good Manufacturing Practices and Inspections. WHO Press.
- Singh, A., Malviya, S., & Kharia, A. (2014). Demand of Pharmaceutical facility functionality: Validation and qualification of HVAC system. Asian Journal of Pharmaceutics, 10 (3), 125-129.
- Choudhary, N., & Sekhon, B. S. (2011). An overview of advances in the standardization of herbal drugs. Journal of Pharmaceutical Education and Research, 1(2), 55.
- World Health Organization. (2006). Annex 4. Supplementary Guidelines on Good Manufacturing Practices: Validation. World Health Organization Technical Report Series, No. 937, 116–121.
- Sugarman, S. C. (2005). HVAC Fundamentals. The Fairmont press, Inc, 1–3.
- World Health Organization. (2017). Quality assurance of pharmaceuticals 2016: WHO guidelines, good practices, related regulatory guidance and GXPs training materials.
- Kohli, R. (2017). Gas-Phase Cleaning for Removal of Surface Contaminants. In R. Kohli (Ed.), Developments in Surface Contamination and Cleaning: Methods for Surface Cleaning (pp. 27-82). William Andrew Publishing.
- International Organization for Standardization. (2015). International Clean Room Standards, ISO 14644. Geneva, International Organization for Standardization.
- International Organization for Standardization. (2015). ISO 14644-1:2015 Clean rooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration.
- European Commission. (2022). EU GMP Annex 1-EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Annex 1-Manufacture of Sterile Medicinal Products.
- World Health Organization. (2011). WHO TRS No. 961 Annex 6: WHO good manufacturing practices for sterile pharmaceutical products.
- International Organization for Standardization. (2005). ISO 14644-3:2005 (en) - Clean rooms and associated controlled environments — Part 3: Test methods.
- ISPE Baseline Guide. (2017). Volume 1: Sterile Pharmaceutical Manufacturing Facilities. International Society for Pharmaceutical Engineering.
- U.S. Food and Drug Administration. 21 CFR part 11 & 21 CFR 210 GMP for finished pharmaceuticals.
- International Conference on Harmonisation. (2005). Quality risk management Q9. In *International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use.
- Breuer, D., & Bower, J. (Eds.). (1999). Monitoring ambient air quality for health impact assessment*. WHO Regional Office Europe.
- Suriyaprakash, T. N. K. (2010). Cleaning validation and its importance in pharmaceutical industry. *PharmaTimes, 42*, 21-24.
- Pharmaceutical Inspection Convention. (2007). “Recommendations on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation and Cleaning Validation”.
- International Conference on Harmonization (ICH). (2005). Harmonised tripartite guideline Q2 (R1), Validation of analytical procedures: Text and methodology.
- World Health Organization. (2006). Supplementary guidelines on good manufacturing practices. Validation. *WHO Technical Report Series, No. 937*, Annex 4.
- Li J, Poulton G. Dynamic zone modeling for HVAC system control. Int J Model Ident Control April 2010;9:5–14.
- Straker M. Clean rooms and air handling systems: design for compliance. Pharm Technol Eur 2005:1–3.
Heating, ventilation, and air conditioning
(HVAC) systems plays a critical role in pharmaceutical
manufacturing facilities by ensuring the integrity of
product quality, safety, and compliance with regulatory
requirements. HVAC validation is an essential process
that verifies and documents the performance and
effectiveness of these systems. This review paper explores
various strategies and approaches to HVAC validation in
pharmaceutical manufacturing facilities, including
regulatory considerations, validation methodologies, risk
assessment, and ongoing monitoring. The paper also
discusses the challenges associated with HVAC validation
and presents best practices to improve the effectiveness of
the validation process.
Keywords :
Heating, Ventilation, and Air Conditioning (HVAC), Validation.