The GMP Handbook - quality systems for the pharmaceutical industry

Date: 16/11/2009 15:19:14

Author: Bob Hayes

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After thousands of training hours in the Pharmaceutical industry, Anna Lundén has earned a good understanding for what kind of GMP knowledge that is requested, both for the employees in this industry as well as for people in adjacent companies as suppliers, consultants and contractors.

Anna Lundén has gathered the most important facts in one book:

• Basic knowledge about GMP in a clear and easy to read style
• Key tables about similarities and differences in the three most common GMP regulations:
  • EU GMP Guideline Part I for medicinal products
  • EU GMP Guideline Part II for manufacturing of active substances used as starting materials (corresponds to ICH Q7 “GMP for API”)
  • 21 CFR 210/211 "Current Good Manufacturing Practice for Finished Pharmaceuticals” (US / FDA)
• Tables with specific references to requirements in the GMPs
• Suitable for self study and to note references to one’s own activities