Annex 12 – Use of Ionising Radiation in the Manufacture of Medicinal Products – 2020

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Annex 12 PICS - Annex 12 - ionising radiation PICS Annex 12

This interactive e-Learn module provides an understanding of the GMP regulations relating to the use of ionising radiation in the manufacture if medicinal products.

The objectives of this training module are:

  • to understand the principles of irradiation techniques
  • to understand the applications and limitations of irradiation techniques
  • to understand the responsibilities of manufacturers and contract irradiation facilities
  • to understand particular validation requirements
  • to understand the specific commissioning and premise requirement
  • to understand dosimetry and processing requirements