Chapter 7. Product Verification and the Role of Qualified Personnel

  1. Dipak K. Sarker

Published Online: 24 DEC 2009

DOI: 10.1002/9780470773031.ch7

Quality Systems and Controls for Pharmaceuticals

Quality Systems and Controls for Pharmaceuticals

How to Cite

Sarker, D. K. (2008) Product Verification and the Role of Qualified Personnel, in Quality Systems and Controls for Pharmaceuticals, John Wiley & Sons, Ltd, Chichester, UK. doi: 10.1002/9780470773031.ch7

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:

  • effective QA and qualified person (QP) skills;
  • product verification and qualified personnel (QP) role;
  • tablet manufacture and batch documentation;
  • batch documentation - product form and dosage strength;
  • Standard operating procedures (SOPs);
  • European Medicines Evaluation Authority (EMEA);
  • drug manufacture processes and working standard operating procedures (wSOPs);
  • QA administration and management policies

Summary

This chapter contains sections titled:

  • Batch documentation

  • Standard operating procedures

  • Guides, overviews and validation plans

  • The duties of the qualified person