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Regulation & Policy

Validation of Pharmaceutical Processes, 3rd edition


Publication Date   September 2007
Publisher   Informa Healthcare
Product Type   Book
Pages   1000
ISBN Number   978-0-8493-7055-7
Product Code   IFH186
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Price £170.00

approximately: $261 | €200

Summary


Helping researchers avoid obstacles that may be encountered at any stage of the validation process, this Third Edition contains new chapters on validation in multinational and small companies, process analytical technology, and international validation methods-detailing the design of systems, the qualification of equipment, processes in calibration and certification, and procedures for the validation of systems for the preparation of aseptic and non-aseptic pharmaceutical products

Content


  • Introduction
  • Support and Utility Systems
  • Sterilization, Sanitization and Sterility Assurance
  • Sterile Product Manufacturing
  • Secondary Manufacturing (Non- Sterile Dosage Forms). Primary Manufacturing
  • Manufacturing Related Activities
  • Computerized Systems
  • Laboratory Methods and Quality Assurance
  • General Topics