Chapter 4. Validation

  1. Dipak K. Sarker

Published Online: 24 DEC 2009

DOI: 10.1002/9780470773031.ch4

Book Title

Quality Systems and Controls for Pharmaceuticals

Quality Systems and Controls for Pharmaceuticals

Additional Information

How to Cite

Sarker, D. K. (2009) Validation, in Quality Systems and Controls for Pharmaceuticals, John Wiley & Sons, Ltd, Chichester, UK. doi: 10.1002/9780470773031.ch4

Author Information

  1. School of Pharmacy and Biomolecular Sciences, University of Brighton, UK

Publication History

  1. Published Online: 24 DEC 2009
  2. Published Print: 15 AUG 2008

ISBN Information

Print ISBN: 9780470056929

Online ISBN: 9780470773031

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CHAPTER TOOLS

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Keywords:

  • validation - planned series interactive tests and inspection;
  • validation and laboratory information management systems (LIMS);
  • Shewhart's PDCA cycle of general validation activities;
  • process and manufacturing validation activities;
  • process validation (PV) centres and individual qualification (tests);
  • process validation and programmable logic controller (PLC);
  • in-process (IPC) or on-process control (OPC);
  • specific clean-in-place (CIP), wash-in-place (WIP) or steam-in-place (SIP) practices;
  • HACCP and hazard and operability (HAZOP) study

Summary

This chapter contains sections titled:

  • Process and manufacturing validation activities

  • Valid analytical methodologies (VAMs)

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