Name: Sterile Manufacturing: Regulations, Processes, and Guidelines (en Inglés)
SKU: 62973671
Price: 57.88 USD
Availability: InStock
Author: Sam A. Hout

portada Sterile Manufacturing: Regulations, Processes, and Guidelines (en Inglés)

Sterile Manufacturing: Regulations, Processes, and Guidelines (en Inglés)

Formato

Libro Físico

Editorial

Crc Press

Autor

Sam A. Hout

Idioma

Inglés

N° páginas

190

Encuadernación

Tapa Blanda

ISBN13

9780367754372

N° edición

Sterile Manufacturing: Regulations, Processes, and Guidelines (en Inglés)

Sam A. Hout (Autor) · Crc Press · Tapa Blanda

Libro Nuevo Importado

Envío: 22 a 29 días háb.

$ 115.76$ 57.88

-50%

Costos de importación incluídos en el precio ✅

Libro Nuevo

Quedan 34 unidades

$ 57.88

Llega entre el 22 Sep y el 05 Oct a Quito, Pichincha. Seleccionar ubicación

Agregar a lista de deseos

Reseña del libro "Sterile Manufacturing: Regulations, Processes, and Guidelines (en Inglés)"

This book highlights key ideas and factors to coach and guide professionals involved in learning about Sterile Manufacturing and operational requirements. It covers regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA, and ICH, emphasizing good manufacturing practice and inspection requirements in the manufacturing of medicinal products. Additionally, this book provides the fundamentals of aseptic techniques, quality by design, risk assessment, and management in support of sterile operations applications. It creates a link to the implementation of business practices in drug manufacturing and healthcare and forms a correlation between design strategies including a step-by-step process to ensure reliability, safety, and efficacy of healthcare products for human and animal use. The book also provides a connection between drug production and regulated applications by offering a review of the basic elements of sterile processing, and how to remain viable with solid strategic planning. The book is a concise reference for professionals and learners in the field of sterile operations that governs primarily, pharmaceutical and medical device space, but can also extend to food and cosmetics that require clean (aseptic) manufacturing applications. It also helps compounding pharmacists and GMP inspectors and auditors.