Guidelines on heating, ventilation and air-conditioning systems for non-sterile pharmaceutical products

Background:

The World Health Organization (WHO) published the first edition of the WHO Guidelines on good manufacturing practices for heating, ventilation and air conditioning systems for non-sterile pharmaceutical dosage forms in 2006 (1). After a revision, the second edition of the document was published in 2011 (2). Consideration of various comments and questions related to good manufacturing practices (GMP) for heating, ventilation and air-conditioning (HVAC) systems led to the proposal to revise the document. After wide public consultation, and taking into account comments received, the document and comments were discussed during an informal consultation in Geneva in April 2017.

During this informal consultation the proposed changes based on comments received as well as additional suggestions made during the consultation, were discussed. It was agreed that the guidelines be amended to comprise two documents: one that would consist of guidelines containing recommendations for GMP for HVAC systems for non-sterile products and a second document that would contain examples and drawings that would clarify some of the recommendations made in the first document.

Therefore, the previous version of the WHO guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms as published in 2011 (2) should be amended according to these new guidelines.

Summary of main changes:

In accordance with the recommendation made during the informal consultation in April 2017, the guidelines have been rewritten in two parts. The present document is the first part and contains the recommendations that are to be considered as good practices in design, management, control and qualification over the life cycle of HVAC systems.

The second part will contain non-binding examples, clarifications and drawings in support of the guidelines in the present document and is currently being drafted.

No summary of changes is provided here, as the content of the previous guidelines has been reorganized taking into account all the comments received during the last comment period.

The illustrative guidance and explanations (second part) will be published separately.

Click on the following title for full details: pdf

Table of Contents

5. Design of HVAC systems and components

6. Full fresh air systems and recirculation systems

7. Air filtration, airflow direction and pressure differentials

8. Temperature and relative humidity

9. Dust, vapour and fume control