News about GMP/cGMP

27.05.2016

WHO: Draft for Supplementary Guidelines on GMP for HVAC Systems

The WHO has revised its 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. A draft has been published for public consultation.

 

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. 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.

Summary of 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 manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms.

  1. 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.
  2. The HVAC sections have been rearranged into a more logical sequence.
  3. 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.
  4. Significant notes were added under the new Supplementary notes on test procedures section.
  5. The Maintenance section has been separated out of the C, Q & V section.
  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 provide better understanding and avoid ambiguity.

Comments should be sent to the WHO by 12 July 2016.


Source:

WHO Quality Assurance Documents

 



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