CRED Managing Variations Effectively

Chapter D – PMF / VAMF

• This section includes changes applicable to a PMF (Plasma master file) & VAMF (Vaccine antigen master file). • PMF is certified by EMA and contains all the information of quality and safety of blood used as starting material of plasma derived medicinal products. • The plasma master file (PMF) is a compilation of all the required scientific data on the quality and safety of human plasma relevant to the medicines that use human plasma in their manufacture. These data cover all aspects of the use of plasma, from collection to plasma pool. • It includes information on collection centres, testing of donations /pools, containers, storage, transport . • This section does not apply to dossiers of medicinal products.

76 Introduction to Classification of CMC (Quality) / Clinical / PhV Variations