The World Health
Organization has issued a draft guidance, titled “Supplementary guidelines on
Good Manufacturing Practices for Heating, Ventilation and Air-Conditioning
Systems for Non-Sterile Pharmaceutical Dosage Forms.”
The scope of the
document is:
“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
(such as liquids, cream, ointments) and other classes of products including
biological products, herbal medicines, complementary medicines and finishing
process steps for APIs.”
In terms of the
change process, during the consultation on data management, bioequivalence, GMP
and medicines’ inspection held in 2015 the possible revision of the guidance
for (WHO Technical Report Series, No. 961, Annex 5, 2011) was discussed with
the inspectors. It was suggested that in light of the new developments a draft
for revision be prepared. This new proposal for revision was drafted based on
the feedback received, the new, current trends in engineering and the
experience gained during the implementation of this guidance in inspection.
At the same time,
the opportunity was used to improve the graphic images and make them more
readable in e-version as well as in print.
The document
reference is Working document QAS/15.639/Rev.1, and it is dated May 2016.
Posted by Dr. Tim Sandle
