Pharmaceutical Manufacturing Deviation and Failure Investigations
portes grátis
Pharmaceutical Manufacturing Deviation and Failure Investigations
Principles, Practices, and Case Studies
Sharma, Sanjay; Pazhayattil, Ajay Babu
Springer International Publishing AG
03/2025
152
Dura
Inglês
9783031865039
15 a 20 dias
Descrição não disponível.
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.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Pharmaceutical Science;Pharmaceutical Manufacturing;Pharmaceutical Industry Investigations;Deviation In Pharmaceutical Manufacturing;Science-Based Investigation Techniques;Corrective And Preventive Actions (CAPA);Data-driven Pharmaceutical Investigations;Regulatory Risk Reduction in Pharmaceuticals;Systematic Investigation Methodologies;Root Cause Analysis (RCA) Methods;Supporting Data Generation;Analytical Tools for Investigations;Laboratory Investigations;Impact Assessment (Vertical and Horizontal) post-RCA;Packaging-Related Investigation
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.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Pharmaceutical Science;Pharmaceutical Manufacturing;Pharmaceutical Industry Investigations;Deviation In Pharmaceutical Manufacturing;Science-Based Investigation Techniques;Corrective And Preventive Actions (CAPA);Data-driven Pharmaceutical Investigations;Regulatory Risk Reduction in Pharmaceuticals;Systematic Investigation Methodologies;Root Cause Analysis (RCA) Methods;Supporting Data Generation;Analytical Tools for Investigations;Laboratory Investigations;Impact Assessment (Vertical and Horizontal) post-RCA;Packaging-Related Investigation
