Thursday, 14 July 2016

GMPs for HVAC in non-sterile pharma


The World Health Organization has issued a draft guidance, titled “Supplementary guidelines on Good Manufacturing Practices for Heating, Ventilation and Air-Conditioning Systems for Non-Sterile Pharmaceutical Dosage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.

The document can be found here: WHO

The closing date for comments is July 12, 2016.

Posted by Dr. Tim Sandle