Drugmakers’ Guide to Global Quality API Manufacturing

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Published by Maas & Peither AG and distributed by FDAnews Drugmakers’ Guide to Global Quality API Manufacturing is the last word on current regulations, guidelines, and auditing standards for APIs.

In its pages you’ll discover clear plain-English explanations of dozens of pressing manufacturing quality issues, including —

  • How regulators in various countries define APIs, including separate, highly detailed sections on biotech and chemical active substances …
  • How to prepare for and conduct audits of API suppliers, particularly those in China and India where most active substances are now produced …
  • How to jump through the new regulatory hoops of import authorization, written confirmation and marketing authorization to get your APIs into EU markets …
  • How to register APIs in various countries …
  • How and when to obtain an EU, PIC/S, WHO or other GMP certificate for an API manufacturer …
  • And much more!

Drugmakers’ Guide to Global Quality API Manufacturing also features a walk-through of recent revisions to GMP-compliant manufacturing standards, testing, and proper movement of APIs within the EU, including vital documents and other essentials for registration. This section alone is worth the full purchase price.

Meet the Authors

Dr. Rainer Gnibl is a GMP inspector for the European Medicines Agency (EMA) and has served in the same capacity for the government of Bavaria, Germany. Gnibl is a pharmacist and head of National Expert Group EFG2 on inspections and GMP Guidelines and has served as the head of API-Group at Central GMP-/GCP Surveillance Bavaria. He lectures on pharmaceutical legislation at University of Erlangen-Nürnberg in Germany, and has published and lectured in Germany and internationally on that topic and GMP.

Dr. Stefan Kettelhoit is the founder and managing director of Blue Inspection Body GmbH, Europe’s leading service provider of accredited GMP audits of manufacturers of excipients and active substances. Kettelhoit has worked in development, production and quality management for Implanta and in international project management for Bayer. He has done presentations and publications on GMP compliance and auditing with a focus on APIs and excipients, as well as on pharmaceutical packaging.

The topic couldn’t be timelier. FDA concerns about falsification have been on the rise as more and more APIs stream in from China, India and other nations where standards may be evolving.

Apply quality risk management to every level of your manufacturing process — starting with APIs from abroad. Order your copies of Drugmakers’ Guide to Global Quality API Manufacturing TODAY.

Order Your Copy Today!

PDF Edition


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Table of Contents

  • Introduction
  • Differences Between API Manufacturing and Drug Manufacturing
  • How Regulators Define Active Substances
  • Global Active Substance Regulations
  • And More …

View the entire TOC

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