All ebooks by Ajay Babu Pazhayattil in PDF and EPUB
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All ebooks by Ajay Babu Pazhayattil in PDF and EPUB


2  Book(s)
Download this eBook 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...

Publication date: 2025-03-20
Format: PDF, ePub
Publisher: Springer
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£89,50
Download this eBook 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...

Publication date: 2018-11-16
Format: PDF, ePub
Publisher: Springer
Collection: AAPS Introductions in the Pharmaceutical Sciences
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£89,50

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