Division b) ContentF1

The Vaccine Antigen Master File shall contain the following information extracted from the relevant part (Active substance) of Module 3 on ‘ Quality Data ’ as delineated in Part I of this Annex:

• Active Substance

  1. 1..

     General Information, including compliance with the relevant monograph(s) of the European Pharmacopoeia.

  2. 2..

     Information on the manufacture of the active substance: this heading must cover the manufacturing process, information on the starting and raw materials, specific measures on TSEs and adventitious agents safety evaluation and facilities and equipment.

  3. 3..

     Characterisation of the active substance

  4. 4..

     Quality control of the active substance

  5. 5..

     Reference standard and materials

  6. 6..

     Container and closure system of the active substance

  7. 7..

     Stability of the active substance.