An edition of The Challenge of CMC Regulatory Compliance for Biopharmaceuticals (2004)
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
By John Geigert
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Publish Date
2004
Publisher
Springer US,Imprint,Springer
Language
eng
Pages
367
Description:
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.