Annex 13 – Manufacture of Investigational Medicinal Products – 2020

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GMP for AMI API investigational medicinal products

This interactive e-Learning module provides the participant with an understanding of the GMP regulations relating to the preparation of medical products for clinical trials. This module is suitable for production, quality, clinical and research personnel involved in the supply and development of investigational medicinal products.

The objectives of this training module are:

  • to provide an understanding of the common terminology used when discussing the manufacture of investigational medicinal products
  • to provide an understanding of validation expectations
  • to provide an understanding of personnel responsibilities and training requirements
  • to provide an understanding of methods used to prevent cross-contamination
  • to provide an understanding of the requirements for the Product Specification file
  • to provide and understanding of Quality Control and Quality Management in relation to these products
  • to provide an understanding of the specific requirements for the complaints, recalls, returns and destruction procedures.