Good Pharmaceutical Manufacturing Practice

Rationale and Compliance

AvJohn Sharp

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Engelska, 2004

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Beskrivning

With over twenty different official regulatory statements worldwide on Good Manufacturing Practice (GMP) for pharmaceutical, drug, or medicinal products, two stand out as being the most influential and most frequently referenced.Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceuti

Produktinformation

Utgivningsdatum:2004-10-15
Språk:Engelska
Filformat:EPUB
Kopieringsskydd:LCP
ISBN:9781135492397
Förlag:Taylor & Francis Ltd

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Recensioner i media

"…provides a pleasantly different approach to the destination of GMP compliance….represents a superb no-nonsense approach to the subject matter and will maintain its value well into the future."-European Journal of Parenteral and Pharmaceutical Sciences"…gives an immediate and good overview of the differences and similarities between the US and EU interpretation of…how to deal with Good Manufacturing Practices."--GMP Review

Innehållsförteckning

Introduction - Status and Applicability of U.S. Regulations/E.U. Guidelines - General Quality Issues. Personnel, Organization and Training. Premises/Buildings and Facilities. Contamination and Contamination Control. Equipment. Materials Control. Production and Process Controls. Packaging and Labeling Control. Holding and Distribution. Laboratory Controls. Records and Reports. Returned and Salvaged products. Sterile Products Manufacture. Other GMP Issues.