Risk-based Management of GMP Audits

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Sprache: Englisch

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Beschreibung

Within the European Union the manufacturing of medicinal products has undoubtedly reached a very high quality level. The principles of Good Manufacturing Practice (GMP) are required by law. A relevant part of the quality of finished products depends on the quality of the starting material, especially of the active pharmaceutical ingredients (APIs). In the framework of globalisation and due to the ever-increasing cost pressure APIs are meanwhile sourced in a worldwide market, mainly in Asia. The risk of sourcing substandard, contaminated or adulterated products is an existent fact. Therefore, the quality management systems of the pharmaceutical manufacturers need to be adjusted to this challenge. Many initiatives have been started by authorities and the pharmaceutical industry during the last years in order to avoid the use of Counterfeit APIs or Rogue APIs and unclear supply chains. Indeed, full assessment of GMP compliance of API suppliers represents a cost-intensive and resource-requiring process. Setting reasonable priorities in the audit programme of a pharmaceutical company becomes possible through a risk-based management.

Details

Erscheinungsjahr:	2010
Fachbereich:	Management
Genre:	Wirtschaft
Rubrik:	Recht & Wirtschaft
Medium:	Taschenbuch
Inhalt:	152 S.
ISBN-13:	9783828824447
ISBN-10:	3828824447
Sprache:	Englisch
Einband:	Kartoniert / Broschiert
Autor:	Hieble-Gerhard, Viola
Hersteller:	Tectum-Verlag
Verantwortliche Person für die EU:	Tectum Wissenschaftsverlag Nomos Verlagsgesellschaft mbH & C, Waldseestr. 3-5, D-76530 Baden-Baden, service@nomos.de
Maße:	19 x 150 x 212 mm
Von/Mit:	Viola Hieble-Gerhard
Erscheinungsdatum:	21.09.2010
Gewicht:	0,242 kg