The Challenge of CMC Regulatory Compliance for

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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published in 2004, there have been more than 50 new regulatory guidances released by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH that affect the CMC regulatory compliance of biopharmaceuticals; also the application of biosimilars has been developed in Europe and is under development in the USA. The revised update will be broadened to include not only biopharmaceuticals (biotech drugs) but also other biologics (vaccines, cell therapy, plasma-derived proteins, etc.)

Country	USA
Author	John Geigert
Binding	Hardcover
EAN	9781461469155
Edition	2nd ed. 2013
ISBN	1461469155
IsEligibleForTradeIn	1
Label	Springer
Manufacturer	Springer
MPN	7 black & white illustrations, 17 colour
NumberOfItems	1
NumberOfPages	338
PartNumber	7 black & white illustrations, 17 colour
PublicationDate	2013-05-07
Publisher	Springer
Studio	Springer
ReleaseDate	0000-00-00

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals