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Pharmaceutical Manufacturing Deviation and Failure Investigations Principles, Practices, and Case Studies /

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 indispensable necessity of a rob...

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Bibliographic Details
Main Authors: Pazhayattil, Ajay Babu (Author), Sharma, Sanjay (Author)
Corporate Author: SpringerLink (Online service)
Format: Electronic eBook
Language:English
Published: Cham : Springer Nature Switzerland : Imprint: Springer, 2025.
Edition:1st ed. 2025.
Series:AAPS Introductions in the Pharmaceutical Sciences, 3
Subjects:
Pharmacology.
Pharmacy.
Pharmacovigilance.
Drug Safety and Pharmacovigilance.
Online Access:https://doi.org/10.1007/978-3-031-86504-6
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