Specific WHO Requirements for Dissolution Studies to Support Biowaivers

Within its inspection programme "Prequalification of Medicines", the WHO intends to include sites which have carried out comparative dissolution studies. This relates to tests which have been performed on behalf of pharmaceutical companies to make a request for a biowaiver which would exempt from the realisation of complex, clinical bioequivalence studies. 

Over the past few years, inspections have been performed at drug manufacturers, API manufacturers, QC laboratories and also at sites which conduct bioequivalence studies. As the dissolution data are really important for the biowaiver requests, it is intended to further concentrate in the future on the performance of dissolution testing.

The WHO expects from companies that they perform comparative dissolution studies, e.g. SOPs on mechanical calibration, on performance verification (with the valid standard prednisone tablets) and on cleaning and maintenance and this for each type of dissolution apparatus used in the company.

 The document "Points to Consider for Inspections of Biowaiver Data" concretely describes the following inspection focuses: 

  • Standard Operating Procedures (SOPs, incl. media preparation, type of introducing tablets and capsules, sampling, etc.)
  • Qualification of the equipment/instrument (IQ/OQ)
  • Mechanical calibration of the equipment (incl. traceability to international standards) 
  • System suitability directly before use
  • Protocols on the execution of comparative dissolution studies 
  • Reports based on sufficient documentation of the tests performed
  • Test procedures (concerning the dissolution of the API itself as well as the quantitative amount of the API)
  • Validation of the analytical procedure

Regarding method validation, it is interesting to notice that the WHO indicates a couple of general acceptance criteria on some of the validation parameters.

The following links give you more information about the WHO's Prequalification Programme and the Points to Consider for Inspections of Biowaiver Data.  

Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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