Gespeichert in:
| Titel: | Pharmaceutical Manufacturing Deviation and Failure Investigations Principles, Practices, and Case Studies / |
|---|---|
| Von: |
by Ajay Babu Pazhayattil, Sanjay Sharma.
|
| Person: |
Pazhayattil, Ajay Babu.
author. aut http://id.loc.gov/vocabulary/relators/aut Sharma, Sanjay. |
| Hauptverfassende: | , |
| Körperschaft: | |
| Format: | Elektronisch E-Book |
| Sprache: | Englisch |
| Veröffentlicht: |
Cham :
Springer Nature Switzerland : Imprint: Springer,
2025.
|
| Ausgabe: | 1st ed. 2025. |
| Schriftenreihe: | AAPS Introductions in the Pharmaceutical Sciences,
3 |
| Schlagwörter: | |
| Medienzugang: | https://doi.org/10.1007/978-3-031-86504-6 |
| Zusammenfassung: | 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. |
| Umfang: | 1 Online-Ressource (XIII, 152 p. 49 illus., 38 illus. in color.) |
| ISBN: | 9783031865046 |
| ISSN: | 2522-8358 ; |
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| 520 | |a 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. | ||
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| 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. |
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| spelling | Pazhayattil, Ajay Babu. author. (orcid)0000-0002-9755-8806 https://orcid.org/0000-0002-9755-8806 aut http://id.loc.gov/vocabulary/relators/aut Pharmaceutical Manufacturing Deviation and Failure Investigations [electronic resource] : Principles, Practices, and Case Studies / by Ajay Babu Pazhayattil, Sanjay Sharma. 1st ed. 2025. Cham : Springer Nature Switzerland : Imprint: Springer, 2025. 1 Online-Ressource (XIII, 152 p. 49 illus., 38 illus. in color.) text txt rdacontent computer c rdamedia online resource cr rdacarrier text file PDF rda AAPS Introductions in the Pharmaceutical Sciences, 2522-8358 ; 3 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. 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. Pharmacology. Pharmacy. Pharmacovigilance. Drug Safety and Pharmacovigilance. Sharma, Sanjay. author. aut http://id.loc.gov/vocabulary/relators/aut SpringerLink (Online service) Springer Nature eBook Printed edition: 9783031865039 Printed edition: 9783031865053 Printed edition: 9783031865060 |
| spellingShingle | Pazhayattil, Ajay Babu Sharma, Sanjay Pharmaceutical Manufacturing Deviation and Failure Investigations Principles, Practices, and Case Studies / AAPS Introductions in the Pharmaceutical Sciences, 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. Pharmacology. Pharmacy. Pharmacovigilance. Drug Safety and Pharmacovigilance. |
| title | Pharmaceutical Manufacturing Deviation and Failure Investigations Principles, Practices, and Case Studies / |
| title_auth | Pharmaceutical Manufacturing Deviation and Failure Investigations Principles, Practices, and Case Studies / |
| title_exact_search | Pharmaceutical Manufacturing Deviation and Failure Investigations Principles, Practices, and Case Studies / |
| title_full | Pharmaceutical Manufacturing Deviation and Failure Investigations [electronic resource] : Principles, Practices, and Case Studies / by Ajay Babu Pazhayattil, Sanjay Sharma. |
| title_fullStr | Pharmaceutical Manufacturing Deviation and Failure Investigations [electronic resource] : Principles, Practices, and Case Studies / by Ajay Babu Pazhayattil, Sanjay Sharma. |
| title_full_unstemmed | Pharmaceutical Manufacturing Deviation and Failure Investigations [electronic resource] : Principles, Practices, and Case Studies / by Ajay Babu Pazhayattil, Sanjay Sharma. |
| title_short | Pharmaceutical Manufacturing Deviation and Failure Investigations |
| title_sort | pharmaceutical manufacturing deviation and failure investigations principles practices and case studies |
| title_sub | Principles, Practices, and Case Studies / |
| topic | Pharmacology. Pharmacy. Pharmacovigilance. Drug Safety and Pharmacovigilance. |
| topic_facet | Pharmacology. Pharmacy. Pharmacovigilance. Drug Safety and Pharmacovigilance. |
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