The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

by J., Geigert, John, Geigert

Publisher: Springer
Publication Date: Thursday, January 01, 2004
Number of Pages: 380
ISBN: 0306480409

Book Summary:
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.



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