EMA ADOPTS BIOTECHNOLOGY-DERIVED ACTIVE SUBSTANCES PROCESS VALIDATION GUIDELINE
May 1st, 2016
The ‘committee for medicinal products for human use’ (CHMP) of the European Medicines Agency (EMA) has adopted a guideline for the process validation (the documented evidence that the process, operated within established parameters, can perform effectively) for the manufacture of biotechnology-derived active substances. The text also covers the data requirements for process characterisation (the definition of the commercial manufacturing process that will be reflected in planned master production and control records). A listing of the data to be provided ...
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