Name: Good Manufacturing Practices for Pharmaceuticals: Gmp in Practice (en Inglés)
Price: 83955.00 COP
Availability: InStock
Author: Cooper, B. N.
ISBN: 9781974006328

portada Good Manufacturing Practices for Pharmaceuticals: Gmp in Practice (en Inglés)

Formato

Libro Físico

Autor

B. N. Cooper

Editorial

Createspace Independent Publishing Platform

Año

2017

Idioma

Inglés

N° páginas

150

Encuadernación

Tapa Blanda

Dimensiones

25.4 x 20.3 x 0.8 cm

Peso

0.31 kg.

ISBN13

9781974006328

Categorías

Aplicaciones científicas e innovación tecnológica

Good Manufacturing Practices for Pharmaceuticals: Gmp in Practice (en Inglés)

B. N. Cooper (Autor) · Createspace Independent Publishing Platform · Tapa Blanda

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Reseña del libro "Good Manufacturing Practices for Pharmaceuticals: Gmp in Practice (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 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