Chapter 9. Applications of QA to New Medicinal Products and New Chemical Entities Formulation

  1. Dipak K. Sarker

Published Online: 24 DEC 2009

DOI: 10.1002/9780470773031.ch9

Quality Systems and Controls for Pharmaceuticals

Quality Systems and Controls for Pharmaceuticals

How to Cite

Sarker, D. K. (2008) Applications of QA to New Medicinal Products and New Chemical Entities Formulation, in Quality Systems and Controls for Pharmaceuticals, John Wiley & Sons, Ltd, Chichester, UK. doi: 10.1002/9780470773031.ch9

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

SEARCH

Keywords:

  • laboratory testing - good laboratory practice (GLP) and good clinical practice (GCP);
  • new medicinal product QA applications;
  • drug candidate assembly and initialisation;
  • validation life cycle - URS design tests (DQ) to PQ with VMP, VMR;
  • top-down or bottom-up validations;
  • bottom-up or prospective validation;
  • crucial choice validation method;
  • raw materials and certificate of analysis (CoA)

Summary

This chapter contains sections titled:

  • Start-up and initialisation

  • Raw materials control

  • The validation life cycle

  • Top-down or bottom-up validations