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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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Bibliografiske detaljer
Main Authors: Pazhayattil, Ajay Babu (Author), Sharma, Sanjay (Author)
Institution som forfatter: SpringerLink (Online service)
Format: Electronisk eBog
Sprog:engelsk
Udgivet: Cham : Springer Nature Switzerland : Imprint: Springer, 2025.
Udgivelse:1st ed. 2025.
Serier:AAPS Introductions in the Pharmaceutical Sciences, 3
Fag:
Pharmacology.
Pharmacy.
Pharmacovigilance.
Drug Safety and Pharmacovigilance.
Online adgang:https://doi.org/10.1007/978-3-031-86504-6
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Indholdsfortegnelse:
  • Chapter 1: Initial Actions and Information Gathering
  • Chapter 2: Root Cause Analysis (RCA) Methods
  • Chapter 3: Analytical Tools for Investigation and Generation of Supporting Evidence
  • Chapter 4: Management of Deviation and Failure Investigation
  • Chapter 5: Post-RCA Impact Assessment, CAPA, and Effectiveness Checks
  • Chapter 6: Case Study: Dissolution OOT Observed for an Extended-Release Tablet Formulation
  • Chapter 7: Case Study: OOS Uniformity of Dosage Units (Stratified Samples) for a Capsule Formulation
  • Appendix I: Non-Conformance/Deviation Investigation
  • Appendix II: OOS Failure Investigation
  • Appendix III: Review of CDMO Investigation Report.

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