Buch, Englisch, 194 Seiten
Code of Federal Regulations. Title 21, Food and Drugs, Parts 200 to 299
Erscheinungsjahr 2003
ISBN: 978-3-8055-7699-4
Verlag: S.Karger
Publication of the American Association of Blood Banks. Distributed in USA/Canada exclusively by the American Association of Blood Banks, Bethesda, Md. Basic selling price determined by the AABB
Buch, Englisch, 194 Seiten
ISBN: 978-3-8055-7699-4
Verlag: S.Karger
This section of the 'Code of Federal Regulations' codifies the general and permanent rules established by the Food and Drug Administration (FDA) for prescription drug manufacturers, which also pertains to blood banking establishments. This section addresses current good manufacturing practice requirements for the manufacturing, processing, packing, or holding of drug products, and current good manufacturing practice requirements for finished pharmaceuticals. Included in this section of the regulations are requirements for a quality control unit.