Equiment Qualification in The Pharmaceutical Industry

Steven Ostrove

Informasi Umum

Kode

20.21.2013

Klasifikasi

658.501 - industri

Jenis

Buku - Elektronik (E-Book)

Subjek

Industri Engineering, Pharmaceutical Industry,

No. Rak

Dilihat

236 kali

Informasi Lainnya

Abstraksi

Welcome to a new series of books dealing with various “Aspects in Pharmaceutical Manufacturing.” This series is intended to provide information to those just coming into the industry, guidance for those already working in the industry, and/or those who just want to “brush up” on their knowledge of the various specific aspects of pharmaceutical manufacturing. Each book in the series will be primarily designed to address the WHY and the HOW of specific pharmaceutical aspects, for example, equipment qualification, cleaning, and biotech—upstream and downstream operations.

Examples and references will be provided to help guide and support the information presented. The authors were all selected because of their expertise and their ability to present this knowledge in a clear and concise manner.

Although many of the topics to be covered in this series may been seen in other works and covered in general, each book in this series will cover one specific aspect of the manufacturing process or environment. Reasons behind and the methods needed to implement a compliant program for that aspect of pharmaceutical manufacturing will be explained.

Topics in this series can fill in the gaps in the education of pharmaceutical employees. Knowledge obtained in formal education settings often lacks in real world conditions such as emergencies that are often encountered in pharmaceutical or biotech manufacturing. The information provided to the reader will help stimulate formulating compliant solutions in GMP documentation, resolving problems (getting to the root cause), and more.