The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
By: by John Geigert
Publisher: Springer US; Imprint; Springer
Published: 2004
Place of publication: Boston, MA
Language: eng
Format: [electronic resource] /
Number of pages: 386
ISBN-13: 9781441991317
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.