Annex 02 – Manufacture of Biological Medicinal Products for Human Use – 2020

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This interactive eLearning module covers the GMP regulations relating to the manufacture of biological medicinal products for human use.  This Annex 2 (Biologicals) e-learning training module is suitable for all manufacturing, engineering, warehouse and quality personnel involved in the production of biological medicinal products.

The objectives of this training module are to understand:

  • the different methods by which biological medicinal products may be manufactured and the differing levels and types of regulatory controls
  • the principles of biological manufacturing
  • the personnel requirements
  • the requirements for premises and equipment
  • the requirements for animal quarters and care
  • the importance of documentation
  • production requirements and the importance of Quality Control