Annex 14 – Manufacture of Products Derived from Human Blood or Plasma

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human blood plasma

The objectives of this training module are:

  • to understand the special health considerations associated with products derived from human blood or plasma
  • to understand the requirements for blood and plasma collection
  • to understand the requirements for traceability
  • to understand the Quality Control requirements related to human blood or plasma products

This interactive e-Learning / Online GMP training Annex 14 – module provides the participant with an understanding of the GMP regulations relating to the manufacture of medicinal products from human blood or plasma.

The scope of this Online GMP training course on EU GMP Annex 14 applies only to medicinal products derived from human blood or plasma, fractionated in or imported into the EU and includes the starting material (e.g. human plasma) for these products. In line with the conditions set out in Directive 2003/63/EC, the requirements apply also for stable derivatives of human blood or human plasma (e.g. Albumin) incorporated into medical devices.

The Online GMP training course covers the specific Good Manufacturing Practices (GMP) requirements for processing, storage and transport of human plasma used for fractionation and for the manufacture of medicinal products derived from human blood or plasma. The Annex addresses specific provisions for when starting material is imported from third countries and for contract fractionation programs for third countries.