WHO Draft Guidance on

"Supplementary guidelines on
good manufacturing practices for heating, ventilation and air-conditioning
systems for non-sterile pharmaceutical dosage forms"

·        Background

Duringthe consultation on data management, bioequivalence, GMP and medicines' inspectionheld in 2015 the possible revision of the guidance for (WHO TechnicalReport Series, No. 961, Annex 5, 2011) was discussed with the inspectors. Itwas suggested that in light of the new developments a draft for revision beprepared. This new proposal for revision was drafted based on the feedbackreceived, the new, current trends in engineering and the experience gainedduring the implementation of this guidance in inspection.

At the same time, the opportunity was used to improve the graphic images and makethem more readable in e-version as well as in print.

·        Summaryof main changes

Below is a list of the main changes that have been made to the WHO Technical Report Series,No. 961, 2011, Annex 5: Supplementary guidelines on good manufacturingpractices for heating, ventilation and air-conditioning systems for non-sterilepharmaceutical dosage forms.

1.The Premises section has been moved towards the beginning of thedocument due to its important impact on HVAC designs. In addition the text hasbeen expanded and a number of sample layouts have been included.

2.The HVAC sections have been re-arranged into a more logical sequence.

3.The Commissioning, Qualification and Validation (C, Q & V) sectionhas been aligned with the proposed revisions to the Supplementary GMPValidation TRS937 Annex4 guideline.

4.Significant notes were added under the new Supplementary notes on testprocedures section.

5.The Maintenance section has been separated out of the C, Q & Vsection.

6.All the diagrams have been revised (mainly to achieve better clarity).

7.Throughout the document additional notes have been added and text revised to providebetter understanding and avoid ambiguity.

8.A list of abbreviations has been added.

 Document:

Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms (QAS/15.639)