Good Pharmaceutical Manufacturing Practice: Rationale and Compliance - Tapa dura

Sharp, John

 
9780849319945: Good Pharmaceutical Manufacturing Practice: Rationale and Compliance
Tapa dura
ISBN 10: 0849319943 ISBN 13: 9780849319945
Editorial: CRC Press, 2004

Sinopsis

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 Pharmaceutical Manufacturing Practice: Rationale and Compliance gleans the most important substance from the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs, 2002) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP guide, 2002). The author uses his 40+ years of experience in technical management, production, quality assurance, and distribution within the pharmaceutical industry, offering a hands-on guide to better understand and implement optimal pharmaceutical practices. This book also compares the principle requirements of GMP, and explores the reasoning behind these requirements and ways to comply with them. Relevant topics include personnel, documentation, premises and equipment, production, quality control, self-inspection, recalls, and more. This is an essential guidebook for those who wish to expand their pharmaceutical business in any international capacity.

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Acerca del autor

Sharp, John

"Sobre este título" puede pertenecer a otra edición de este libro.

Editorial
CRC Press
Año de publicación
2004
Idioma
Inglés
ISBN 10 
0849319943
ISBN 13 
9780849319945
Encuadernación
Tapa dura
Número de edición
1
Número de páginas
520
Contacto del fabricante
Taylor and Francis, GPSR Taylor and Francis
gpsr@taylorandfrancis.com

Taylor & Francis Verlag GmbH, Kaufingerstraße 24
München
80331
Alemania

Otras ediciones populares con el mismo título

9780367393779: Good Pharmaceutical Manufacturing Practice: Rationale and Compliance

Edición Destacada

ISBN 10:  0367393778 ISBN 13:  9780367393779
Editorial: CRC Press, 2019
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