Name: The GMP Handbook: A Guide to Quality and Compliance (en Inglés)
Price: 55.15 USD
Availability: InStock
Author: Cooper, Brendan
ISBN: 9781548370251

portada The GMP Handbook: A Guide to Quality and Compliance (en Inglés)

Formato

Libro Físico

Autor

Brendan Cooper

Editorial

Createspace Independent Publishing Platform

Idioma

Inglés

Encuadernación

Tapa Blanda

Dimensiones

25.4 x 20.3 x 0.8 cm

Peso

0.31 kg.

ISBN13

9781548370251

Categorías

Biotecnología

The GMP Handbook: A Guide to Quality and Compliance (en Inglés)

Brendan Cooper (Autor) · Createspace Independent Publishing Platform · Tapa Blanda

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$ 55.15

$ 84.84

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Origen: Estados Unidos (Costos de importación incluídos en el precio)

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Reseña del libro "The GMP Handbook: A Guide to Quality and Compliance (en Inglés)"

CGMP, Current Good Manufacturing Practices has legal and practical implications for manufacturers of medicinal products and medical devices. The requirements to meet CGMP is legal requirement but it also ensures the patient receives products that are safe, effective and of consistent quality. The FDA, WHO, ICH, PIC/s AND Eudralex provide extensive guidance and regulations on many topics related to the manufacture of medicinal and drug products. A large body of reference materials is available to manufacturers and engineering professionals. This book brings together the key requirements of GMP and briefly examines the common themes and requirements published by the various authorities, bodies and international organisations. The book includes the following chapters: Chapter 1-Overview of Good Manufacturing Practices Chapter 2-Quality ManagementChapter 3-PersonnelChapter 4-Buildings and FacilitiesChapter 5-Process EquipmentChapter 6-Documentation and RecordsChapter 7-Materials ManagementChapter 8-Rejection and re-use of materialsChapter 9-ValidationChapter 10- Change Control Chapter 11-Complaints and recallsPage count 160. Paperback book. Large 8" x 10" format.