Chemical Engineering in the Pharmaceutical Industry R D to Manufacturing Charter 1文档.pdfVIP

PART I INTRODUCTION 1 CHEMICAL ENGINEERING IN THE PHARMACEUTICAL INDUSTRY: AN INTRODUCTION DAVID J. AM ENDE Chemical RD, Pfizer, Inc., Groton, CT, USA Although recently several excellent books have been pub- Cosmetics Act as the principal law to enforce and constitutes lished geared toward process chemistry [1–3] or formulation the basis of the drug approval process [6]. Specifically in the development in the pharmaceutical industry [4], relatively United States, ‘‘The FDA is responsible for protecting the little has been published specifically with a chemical engi- public health by assuring the safety, efficacy, and security of neering (ChE) focus. This book, therefore, is about chemical human and veterinary drugs, biological products, medical engineering applied to the process research, development, devices, our nation’s food supply, cosmetics, and products and manufacture of pharmaceuticals. Across the pharmaceu- that emit radiation. The FDA is also responsible for advanc- tical industry, chemical engineers are employed in RD ing the public health by helping to speed innovations that through to full-scale manufacturing in technical and man- make medicines and foods more effective, safer, and more agement capacities. The following chapters provide an em- affordable; and helping the public get the accurate, science- phasis on the application of chemical engineering science to based information they need to use medicines and foods to process development and scale-up for active pharmaceutical improve their health [7].’’ ingredients (APIs), drug products (DPs), and biologicals A review of the structure within the FDA and the drug including sections on analytical methods and computational review process can be found in the cited references [