Title:Regulatory Requirements for Collection, Administration and Transfusion of Blood and Blood Products
Volume: 4
Issue: 1
Author(s): Monika Rani, Raghuvansh Kumar, Gagandeep Kaur and Pawan Krishan
Affiliation:
Keywords:
Blood, blood products, blood regulatory network, regulatory guidelines of blood products, safety and quality
assurance, blood transfusion.
Abstract: Blood is considered as a life saving tissue. World Health Organization (WHO) has considered
“Blood” under the definition of “Drug,” in Drug and Cosmetic Act, 1940. For the first time,
in 1975, WHO World Health Assembly (WHA) under the resolution WHA (28.72), established the
principles and guidelines for the managed and coordinated blood systems. For over fifty years, expert
committee on biological standardization (ECBS), has been playing a key role in developing and updating
norms and standards for collection, processing, storage, transfusion and manufacturing of
pharmaceuticals derived from blood. In 2010, under the resolution WHA (63.12), WHO noted a
number of international concerns about shortage of plasma derived products, unequal access of blood
and blood products globally, quality and safety of blood and blood product transfusion. So, this review
summarizes various regulatory requirements, which need to be followed for safety and quality
assurance systems to control the quality and safety of blood and blood products and provision of safe
blood products to meet the clinical need of patients.
