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Quality systems and controls for pharmaceuticals /

Quality Systems and Control for Pharmaceuticals is an accessible overview of the highly-regulated area of pharmaceutical manufacture, the production of biomedical materials, and biomedical devices. Introducing the subject in a clear and logical manner it enables the reader to grasp the key concepts...

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Bibliographic Details
Main Author: Sarker, Dipak K.
Format: eBook
Language:English
Published: Chichester, England ; Hoboken, NJ : John Wiley & Sons, ©2008.
Subjects:
Pharmaceutical industry > Quality control.
Drugs.
Pharmaceutical industry.
Quality control.
Pharmaceutical technology.
Pharmaceutical Preparations
Drug Industry
Quality Control
Technology, Pharmaceutical
Electronic books.
Online Access:Connect to the full text of this electronic book
Table of Contents:
  • Technology transfer and the climate of change
  • Quality systems structure and a maximum quality environment
  • Validation
  • Good manufacturing practices
  • Process control via numerical means
  • Product verification and the role of qualified personnel
  • In-process and on-process QC testing and control
  • Applications of QA to new medicinal products and new chemical entities formulation
  • New products manufacturing
  • Questions and problems
  • References.