Chapter 8. In-Process and On-Process QC Testing and Control

  1. Dipak K. Sarker

Published Online: 24 DEC 2009

DOI: 10.1002/9780470773031.ch8

Quality Systems and Controls for Pharmaceuticals

Quality Systems and Controls for Pharmaceuticals

How to Cite

Sarker, D. K. (2009) In-Process and On-Process QC Testing and Control, in Quality Systems and Controls for Pharmaceuticals, John Wiley & Sons, Ltd, Chichester, UK. doi: 10.1002/9780470773031.ch8

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:

  • quality control - physical sampling and recovery;
  • valid analytical methods (VAMs) and chemometric evaluation;
  • in-process and on-process QC testing and control;
  • process analytical technologies;
  • analytical validation and clinical test validation (CTV);
  • inter-lab precision and coefficient of variation (COV);
  • laboratory information management system (LIMS) and automation;
  • laboratory manager programs and LIMS-led quality control

Summary

This chapter contains sections titled:

  • Process analytical technologies

  • Analytical validation and clinical test validation (CTV)

  • LIMS and automation