Pharmaceutical Manufacturing Deviation and Failure Investigations : Principles, Practices, and Case Studies / by Ajay Babu Pazhayattil, Sanjay Sharma.

Format:

Book

Author/Creator:

Pazhayattil, Ajay Babu., Author.

Sharma, Sanjay., Author.

Series:

AAPS Introductions in the Pharmaceutical Sciences, 2522-8358 ; 3

Language:

English

Subjects (All):

Pharmacology.

Pharmacy.

Pharmacovigilance.

Drug Safety and Pharmacovigilance.

Local Subjects:

Pharmacology.

Pharmacy.

Drug Safety and Pharmacovigilance.

Physical Description:

1 online resource (XIII, 152 p. 49 illus., 38 illus. in color.)

Edition:

1st ed. 2025.

Place of Publication:

Cham : Springer Nature Switzerland : Imprint: Springer, 2025.

Summary:

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 robust investigation. The textbook thoroughly explores the standard tools and techniques for conducting scientifically grounded and data-driven investigations. Its overarching objective is to elucidate systematic investigation methodologies that yield effective corrective and preventive actions, ultimately reducing regulatory risks. This book offers a comprehensive overview of standard tools and techniques, focusing on science-based and data-driven approaches. Tailored for professionals in pharmaceutical manufacturing, this book is your go-to resource for mastering investigations in the manufacturing of patient-critical pharmaceutical products.

Contents:

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.

ISBN:

3-031-86504-9