Description

Book Synopsis

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.

Pharmaceutical Manufacturing Deviation and

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    A Hardback by Ajay Babu Pazhayattil

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      Publisher: Springer
      Publication Date: Publication Date: 5/13/2025
      ISBN13: 9783031865039, 978-3031865039
      ISBN10: 3031865030
      Also in:
      Pharmacology

      Description

      Book Synopsis

      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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