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Qualification and Experience Requirements and Responsibilities for Key Personnel of Licensed Manufacturers of Medical Products and Health Technologies Kenya

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  • Create Date February 28, 2022
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Qualification and Experience Requirements and Responsibilities for Key Personnel of Licensed Manufacturers of Medical Products and Health Technologies Kenya

  1. 1.1.  This guidance represents the current PPB’s requirement on key personnel involved in batch production and control, batch certification and on eventual batch release by licensed manufacturers of human or veterinary products1 meant for domestic and export markets.
  2. 1.2.  The principles of this guidance also apply to investigational medicinal products (IMP) for human and veterinary use in accordance with legal provisions that may be reviewed from time to time.
  3. 1.3.  The basic arrangements for batch release for a product are defined by its Marketing Authorization (MA). Nothing in this guideline should be taken as overriding those arrangements.

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