10. Good Manufacturing Practice: Drug Manufacturing

  1. Rick Ng PhD, MBA

Published Online: 30 APR 2008

DOI: 10.1002/9780470403587.ch10

Drugs: From Discovery to Approval, Second Edition

Drugs: From Discovery to Approval, Second Edition

How to Cite

Ng, R. (2008) Good Manufacturing Practice: Drug Manufacturing, in Drugs: From Discovery to Approval, Second Edition, John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9780470403587.ch10

Author Information

  1. A-Bio Pharma Pte Ltd, Singapore

Publication History

  1. Published Online: 30 APR 2008
  2. Published Print: 7 NOV 2008

ISBN Information

Print ISBN: 9780470195109

Online ISBN: 9780470403587

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Keywords:

  • good manufacturing practice (GMP) and drug manufacturing;
  • large molecule protein-based API and recombinant DNA methods;
  • finished dosage form - API drug formulated

Summary

This chapter contains sections titled:

  • Introduction

  • GMP Manufacturing

  • GMP Inspection

  • Manufacture of Small Molecule APIs (Chemical Synthesis Methods)

  • Manufacture of Large Molecule APIs (Recombirant DNA Methods)

  • Finished Dosage Forms

  • Case Study #10

  • Summary of Important Points

  • Review Questions

  • Brief Answers and Explanations

  • Further Reading