Structured like a textbook, the second edition of this reference covers all aspects of biopharmaceutical manufacturing, including legal and regulatory issues, production facility design, and quality assurance, with a focus on supply chain management and regulations in emerging markets and cost control. The author has longstanding industrial expertise in biopharmaceutical production and years of experience teaching at universities. As such, this practical book is ideal for use in academia as well as for internal training within companies.Finally, the green area constitutes the safeguarding measures, without which quality management cannot function. ... and implementation of quality management (1), one part of it being a quality system (2) in which the quality- relevant flows are written down and which integrates ... The more general procedures and rules that are described in the quality management manual are at the peak of the pyramid.
|Title||:||Manufacturing of Pharmaceutical Proteins|
|Publisher||:||John Wiley & Sons - 2015-03-20|