Rx-360 summary of the draft WHO HVAC GMPs for non-sterile products

Document is intended to provide guidance to pharmaceutical manufacturers and inspectors of pharmaceutical manufacturing facilities on the design, installation, qualification and maintenance of the HVAC systems.

These guidelines primarily focus on the design and GMP requirements and recommendations for HVAC systems for facilities for the manufacture of non-sterile solid dosage forms. This includes tablets, capsules, powders, liquids, creams and ointments. The HVAC design principles contained in the guidelines may be applied to other dosage forms.

This document is intended to provide guidance to pharmaceutical manufacturers and inspectors of pharmaceutical manufacturing facilities on the design, installation, qualification and maintenance of the HVAC systems. These guidelines are intended to complement those provided in GMPs for pharmaceutical products and should be read in conjunction with the parent guide. The additional standards addressed by the present guidelines should, therefore, be considered supplementary to the general requirements set out in the main principles guide (WHO Technical Report Series, No. 961, Annex 3).

Along with a glossary of terms, this guidance document discusses commissioning, qualification, and validation of HVAC systems, cross-contamination and contamination, HVAC system and component design, protection of products, personnel, and the environment.

Comments are due to WHO by 12 July 2016.