Commentary on GMP
Walter Oeser / Axel Sander
Basic Rules for Manufacturing Medicinal Products & Active Substances
Commentary for pharmaceutical and legal practitioners, Loose-leaf edition in 3 folders
Under the Ordinance on the Manufacture of Medicinal Products & Active Substances (AMWHV), which replaced the Ordinance on the Pharmaceutical Industry (PharmBetrV) that was in force until 9 November 2006, pharmaceutical companies have to produce medicinal products, active substances and certain excipients in accordance with Good Manufacturing Practice (GMP).
The commentary project was jointly launched in 1977 with Dr. Strohecker, Darmstadt. Initially, it was designed merely as an interpretation aid for inspectors’ questionnaires used during official audits, but for nearly 30 years now it has been accompanying the dynamic development of GMP in Germany and later on in Europe as well.
The authors have aimed to summarize interpretations, references and materials on both pharmaceutical and legal issues and for monitoring purposes. Apart from the official texts, the loose-leaf edition contains explanations and further guidelines that are indispensable for drug manufacturers. At the same time, attention is paid to aspects of regulatory monitoring as well as to the increasing internationalization of requirements. Developments are pointed out to indicate the intrinsic purpose of some regulations and illustrate the history of GMP. Material on specific questions completes this practical compendium.
“In this three-volume work, you’ll find everything you’re looking for in connection with GMP” (die pharmazeutische industrie, pharmind)
PhOR Walter H. Oeser, Specialized in Pharmacy for Public Healthcare
Dr. Axel Sander, Attorney-at-Law, Frankfurt am Main.
Click here for the GMP Commentary on the Wissenschaftliche Verlagsgesellschaft website.
© Kanzlei SANDER & KRÜGER