WHO publishes draft guideline for HVAC systems for non-sterile pharmaceutical dosage forms

Recommendation

08 October 2019
Vienna, Austria

Container-/Closure-Integrity Testing of Parenterals

Nearly all guidelines addressing the requirements with regard to HVAC systems or air qualities focus on the manufacture of sterile medicinal products. This is especially true for the Annex 1 of the EU GMP Guideline.

The WHO now published a revised working document of the guideline for public consultation which specifically addresses the requirements for HVAC systems used during the manufacture of non-sterile pharmaceutical dosage forms. The version valid so far dates back to 2011 and is contained in the WHO Technical Report Series, No. 961 as Annex 5 (Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms). The main changes are the integration of sample layouts (such as for weighing and dispensing) in the chapter "Premises" and a revision of the chapter "Commissioning, Qualification and Validation". Furthermore, a separate chapter now is devoted to maintenance.

You can find the current draft of the "Guideline Supplementary guidelines on GMPs for HVAC systems for non-sterile pharmaceutical dosage forms" in the members' area of the ECA website.