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Language: en
Pages: 99
Pages: 99
Type: BOOK - Published: 2018-11-16 - Publisher: Springer
Currently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatory guidance's such as US FDA, EMEA, W
Language: en
Pages: 400
Pages: 400
Type: BOOK - Published: 2011-08-05 - Publisher: Springer Science & Business Media
This book is intended to serve as a resource for analysts in developing and troubleshooting sample preparation methods. These are critical activities in providi
Language: en
Pages: 116
Pages: 116
Type: BOOK - Published: 2019-08-30 - Publisher: Springer Nature
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 lif
Language: en
Pages: 762
Pages: 762
Type: BOOK - Published: 2007-09-25 - Publisher: CRC Press
Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of
Language: en
Pages: 506
Pages: 506
Type: BOOK - Published: 2009-02-09 - Publisher: John Wiley & Sons
There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview
