Chapter 11. Questions and Problems

  1. Dipak K. Sarker

Published Online: 24 DEC 2009

DOI: 10.1002/9780470773031.ch11

Quality Systems and Controls for Pharmaceuticals

Quality Systems and Controls for Pharmaceuticals

How to Cite

Sarker, D. K. (2009) Questions and Problems, in Quality Systems and Controls for Pharmaceuticals, John Wiley & Sons, Ltd, Chichester, UK. doi: 10.1002/9780470773031.ch11

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:

  • GMP - grade production and remedial action;
  • Total Quality Management (TQM) framework;
  • specimen examples and exam questions;
  • copying/evidence of plagiarism and low/high word count;
  • 6-sigma control quality system and routine process control;
  • GCP and drug development and testing;
  • operating characteristic curve (OCC);
  • investigational new drug (IND) and new medicine and process limitations;
  • quality and quality gurus' (DJC) mission statements

Summary

This chapter contains sections titled:

  • Specimen examples and exam questions

  • Model answers to examples