Division b) ContentF1

In accordance with the provisions of Article 109, as amended by Directive 2002/98/EC, which refers to the requirements for donors and the testing of donations, the Plasma Master File shall include information on the plasma used as starting/raw material, in particular:

1. (1)

   Plasma origin

   1. (i)

      information on centres or establishments in which blood/plasma collection is carried out, including inspection and approval, and epidemiological data on blood transmissible infections.

   2. (ii)

      information on centres or establishments in which testing of donations and plasma pools is carried out, including inspection and approval status.

   3. (iii)

      selection/exclusion criteria for blood/plasma donors.

   4. (iv)

      system in place which enables the path taken by each donation to be traced from the blood/plasma collection establishment through to finished products and vice versa.

2. (2)

   Plasma quality and safety

   1. (i)

      compliance with European Pharmacopoeia Monographs.

   2. (ii)

      testing of blood/plasma donations and pools for infectious agents, including information on test methods and, in the case of plasma pools, validation data on the tests used.

   3. (iii)

      technical characteristics of bags for blood and plasma collection, including information on anticoagulants solutions used.

   4. (iv)

      conditions of storage and transport of plasma.

   5. (v)

      procedures for any inventory hold and/or quarantine period.

   6. (vi)

      characterisation of the plasma pool.

3. (3)

   System in place between the plasma-derived medicinal product manufacturer and/or plasma fractionator/processor on the one hand, and blood/plasma collection and testing centres or establishments on the other hand, which defines the conditions of their interaction and their agreed specifications.

   In addition, the Plasma Master File shall provide a list of the medicinal products for which the Plasma Master File is valid, whether the medicinal products have been granted a marketing authorisation or are in the process of being granted such an authorisation, including medicinal products referred to in Article 2 of Directive 2001/20/EC of the European Parliament and of the Council relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.