Ebooks d'Ajay Babu Pazhayattil en PDF et EPUB

2 Livre(s)
Télécharger le livre : Pharmaceutical Manufacturing Deviation and Failure Investigations
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Pharmaceutical Manufacturing Deviation and Failure Investigations
Ajay Babu Pazhayattil , Sanjay Sharma
This book tackles the crucial topic of deviation and failure investigations in the pharmaceutical industry, recognizing their pivotal influence on regulatory outcomes. Extensive assessments, including analyses of US FDA warning letters and 483 reports, underscore the...

Editeur : Springer
Parution : 2025-03-20

PDF, ePub

94,94 €
Télécharger le livre : Solid Oral Dose Process Validation
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Solid Oral Dose Process Validation
Jordan Collins , Emilija Fredro-Kumbaradzi , Ajay Babu Pazhayattil , Naheed Sayeed-Desta
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, WHO, PIC/S have adopted the ICH lifecycle approach. The concepts are now harmonized across regulatory...

Editeur : Springer
Parution : 2018-11-16
Collection : AAPS Introductions in the Pharmaceutical Sciences
PDF, ePub

94,94 €