GLP: Handbuch Für Praktiker Paperback 2

G?nter a. Christ

Since 1990, compliance with the glp principles has been mandatory in germany in the testing of pharmaceuticals, pesticides and chemicals to assess their potential hazards to humans and the environment in the chemicals act. There have been many amendments and additional documents at both national and, above all, international level (oecd or eu). Nationally, both the chemicals act, including annex i (glp principles) and the general administrative regulation on glp (chemvwv-glp) were adapted to the international standard. Internationally, since 1990, eight consensus documents have been produced in mixed working groups at the oecd level. Probably the most important innovation concerns the glp principles of the oecd, which have been extensively revised. All contributions of this second edition have been revised and adapted to the development. The book is divided into four sections. On the one hand, the glp principles and all accompanying documents are commented on from the point of view of an experienced glp inspector. Thereafter, there is detailed guidance, advice, suggestions and interpretations from a senior quality assurance professional with years of practical experience in implementing glp principles, with investigators and with glp inspectors. A third section is devoted to practical notes on the implementation of the much discussed consensus document on "computer aided systems and glp". A quality assurance manager who has been working on this topic since the first hour of introducing computers in the laboratory is setting the standard here. An innovation brings the fourth section. An industrial manager in charge of laboratory equipment who has experience in qm systems looks across the board and also describes other qm systems, such as gmp, gcp, haccp, din and iso standards. Also addressed are practical proof of suitability for laboratory equipment with a focus on qualification, validation and system suitability tests. To help glp stakeholders deal with the revised glp principles, a version of the "revised oecd principles of glp" has been prepared, highlighting the new text in italics in bold type and truncating the text that is no longer valid. This eye-popping comparison will be of great practical use for the user.

3928865250

9783928865258

German

GIT Verlag GmbH

12 April 2010

326

Stephen J. Harston

Hans-Wilhelm Hembeck

Karl-Armin Opfer

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