WHO: Draft on GMP for HVAC-Systems for Non-Sterile Pharmaceuticals

During a consultation on data management, bioequivalence, GMP and medicines inspection held by the WHO in 2015, a revision of the Supplementary Guidelines on Good Manufacturing Practices for Heating, Ventilation and Air-conditioning Systems for Non-sterile Pharmaceutical Dosage Forms was discussed with the inspectors.
In view of current trends in engineering and the experience gained during the implementation of the guidance in inspection a revision of the document published in 2011 was decided.
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.
The opportunity was used to include a number of sample layouts to the “Premises” section and to improve the graphic images in general. 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.
  • All diagrams have been revised.
  • A list of abbreviations has been added.
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