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 ...