Chapter 4. Validation

  1. Dipak K. Sarker

Published Online: 24 DEC 2009

DOI: 10.1002/9780470773031.ch4

Quality Systems and Controls for Pharmaceuticals

Quality Systems and Controls for Pharmaceuticals

How to Cite

Sarker, D. K. (2008) 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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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)