BOOK DOWNLOAD

Solid Oral Dose Process Validation, Volume Two: Lifecycle Approach Application

10.00$
Solid Oral Dose Process Validation, Volume Two: Lifecycle Approach Application
BOOK DOWNLOAD

Solid Oral Dose Process Validation, Volume Two: Lifecycle Approach Application

10.00$

(AAPS Introductions in the Pharmaceutical Sciences) 1st ed. 2019 Edition 

by Ajay Pazhayattil (Author), Naheed Sayeed-Desta (Author), Emilija Fredro-Kumbaradzi (Author), Marzena Ingram (Author), Jordan Collins (Author) 

The textbook addresses the lifecycle concepts (Stage 1, 2, 3) of Process Validation. Regulatory bodies such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. Organizations have an opportunity to harmonize and align PV activities for all regulated markets. The concepts discussed provides a direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Oral Dose Process Validation, Lifecycle Approach: Application, Volume Two and the companion Volume One, Solid Dose Process Validation, The Basics, also available as a set, provide directions and solutions for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach. This set is published as a comprehensive solution for solid dose process validation.

Year:
2019
Pages:
116
Language:
English
Format:
PDF
Size:
6 MB
Publisher:
Springer
ISBN-10:
3030274837
ISBN-13:
978-3030274832
ASIN:
B07X96PD3F
Tag:
Download Book Solid Oral Dose Process Validation, Volume Two: Lifecycle Approach Application