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Guidelines on heating, ventilation and air-conditioning systems for non-sterile pharmaceutical products
Part 2: Interpretation of Guidelines on heating, ventilation and air-conditioning systems for non-sterile pharmaceutical products
Background:
The World Health Organization (WHO) published the first edition of its Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms in 2006 (1).
Having considered various comments and the recommendations through public consultation over several years, the WHO Expert Committee on Specifications for Pharmaceutical Preparations agreed, during its Fifty-first meeting held in October 2017, that the Supplementary guidelines for good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms guidelines, as amended, be adopted as Part 1 (2).
It was agreed that Part 1 consists of guidelines that contain recommendations on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile products, and further agreed that Part 1 be supported by an additional document that reflects the interpretation of the recommendations in Part 1.
This document is Part 2 and will be considered for adoption as such after consultation.
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Table of Contents
WHO TRS (Technical Report Series) 1019, 2019 Annex 2:
