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Draft Supplementary guidelines on GMP HVAC systems released by WHO

The WHO has released supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms. During the consultation on data management, bioequivalence, GMP and medicines’ inspection held in 2015 the possible revision of the guidance was discussed with the inspectors.

The draft has been released for public consultation on account of revision of WHO’s Technical Report Series, No. 961, 2011, Annex 5: Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms. Comments on the draft have been requested by 12 July 2016.

Summary of the changes of the document includes:


• The Premises section has been moved towards the beginning of the document due to its important impact on HVAC designs. In addition the text has been expanded and a number of sample layouts have been included.
• The HVAC sections have been rearranged into a more logical sequence.
• The Commissioning, Qualification and Validation (C, Q & V) section has been aligned with the proposed
revisions to the Supplementary GMP Validation TRS, No. 937, Annex 4 guidelines.
• Significant notes were added under the new Supplementary notes on test procedures section.
• The Maintenance section has been separated out of the C, Q & V section.
• All the diagrams have been revised mainly to achieve better clarity.
• Throughout the document additional notes have been added and text revised to provide better understanding and avoid ambiguity.


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