WHO Issues Revised Annex 5: Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms, July 2011.
This modified annex is meant to supplement the GMPs and address basis non-sterile dosage form HVAC considerations. The primary areas covered in this annex are the roles that the HVAC system plays in product protection, personnel protection, and environmental protection. The annex does reference ISO 14644 for qualification and validation for particle count, air pressure differences, airflow volume, airflow velocity, filter leakage tests, containment leakage, recovery and airflow visualization.
This is a useful guideline for consideration when addressing facility redesign, new facility design, or when assessing a CMO’s compliance with HVAC operations and maintenance.