The Challenge of CMC Regulatory Compliance for

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
Brand Springer
Manufacturer Springer
Binding Hardcover
ItemPartNumber 7 black & white illustrations, 17 colour
ReleaseDate 2013-05-07
UnitCount 1
EANs 9781461469155

Country	USA
Brand	Springer
Manufacturer	Springer
Binding	Hardcover
ItemPartNumber	7 black & white illustrations, 17 colour
ReleaseDate	2013-05-07
UnitCount	1
EANs	9781461469155

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals