Author: ChongN

cGMP History

CFR Regulation

Blood as a Drug and Biologic

Food and Drug Administration (FDA):
is responsible for protecting and promoting public health
Current Good Manufacturing Practices (cGMP): is a production and testing practice that helps to ensure a quality product, enforced by the US FDA
Code of Federal Regulations (CFR): is the codification of the general and permanent rules and regulations

Drug
-Purity, Safety, Effectiveness
Recognized in the US Pharmacopeia
Provide treatment
Prevention of diseases

Center for Biologics Evaluation and Research (CBER)
Improved products and customer satisfaction
Consistent, reliable systems for production
Decreased product discards, rework, shortages
Decreased regulatory problems
Improved work environment
Blood donation safety is contingent on five things:
Accurate educational material for donors to assess risk
Sensitive communication of donor screening questions
Donor honesty and understanding
Infectious disease marker testing which is quality controlled
Appropriate handling of blood products for clinical use

Biologic
-Safety, Purity, Potency
Examples: vaccines, blood and blood components, allergenic, somatic cells, gene therapy, tissue, recombinant therapeutic proteins.
They can be composed of sugars, proteins, or ncleic acids, or any combination of these substances.
Regulated by Center for Biologics Evaluation & Research (CBER)