Rx-360 summary of WHO supplementary guidelines on GMP for HVAC systems for non-sterile pharmaceuticals

These guidelines primarily focus on recommendations for systems for manufactures of solid dosage forms.

This update also includes improved graphic images to make them more readable. These guidelines primarily focus on recommendations for systems for manufactures of solid dosage forms. The guidelines also refer to other systems or components which are not relevant to solid dosage for manufacturing plants, but which may assist in providing a comparison between the requirements for solid dosage-form plants and other systems.

This document provides 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 "Good manufacturing practices 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 parent guide. In addition, these guidelines are not intended to be prescriptive in specifying requirements and design parameters.

These guidelines focus primarily on the design and good manufacturing practices (GMP) requirements for HVAC systems for facilities for the manufacture of solid dosage forms. Most of the system design principles for facilities manufacturing solid dosage forms also apply to facilities manufacturing other dosage forms and other classes of products including biological products, herbal medicines, complimentary medicines and finishing process steps for APIs. Additional specific requirements apply for handling of sterile products and hazardous products. Guidelines for hazardous, sterile and biological product facilities are covered in separate WHO guidelines.