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Pharmaceutical Manufacturing Deviation and Failure Investigations : Principles, Practices, and Case Studies / / by Ajay Babu Pazhayattil, Sanjay Sharma
| Pharmaceutical Manufacturing Deviation and Failure Investigations : Principles, Practices, and Case Studies / / by Ajay Babu Pazhayattil, Sanjay Sharma |
| Autore | Pazhayattil Ajay Babu |
| Edizione | [1st ed. 2025.] |
| Pubbl/distr/stampa | Cham : , : Springer Nature Switzerland : , : Imprint : Springer, , 2025 |
| Descrizione fisica | 1 online resource (XIII, 152 p. 49 illus., 38 illus. in color.) |
| Disciplina | 615 |
| Collana | AAPS Introductions in the Pharmaceutical Sciences |
| Soggetto topico |
Pharmacology
Pharmacy Pharmacovigilance Drug Safety and Pharmacovigilance |
| ISBN | 3-031-86504-9 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 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. |
| Record Nr. | UNINA-9910988285203321 |
Pazhayattil Ajay Babu
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| Cham : , : Springer Nature Switzerland : , : Imprint : Springer, , 2025 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Technology Transfer : Drug Product Manufacturing Process / / by Ajay Babu Pazhayattil, Sanjay Sharma, Joe Paul Philip, Michelle Gischewski-Silva, Marzena Ingram
| Technology Transfer : Drug Product Manufacturing Process / / by Ajay Babu Pazhayattil, Sanjay Sharma, Joe Paul Philip, Michelle Gischewski-Silva, Marzena Ingram |
| Autore | Pazhayattil Ajay Babu |
| Edizione | [1st ed. 2023.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2023 |
| Descrizione fisica | 1 online resource (158 pages) |
| Disciplina |
615.1
615.19 |
| Altri autori (Persone) |
SharmaSanjay
PhilipJoe Paul Gischewski-SilvaMichelle IngramMarzena |
| Collana | AAPS Introductions in the Pharmaceutical Sciences |
| Soggetto topico |
Pharmacy
Pharmaceutical chemistry Pharmacology Drug delivery systems Pharmacovigilance Pharmaceutics Drug Delivery Drug Safety and Pharmacovigilance |
| ISBN | 3-031-32192-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Chapter 1: Current Status of Technology Transfer -- Chapter 2: Quality by Design (QbD) Process Design -- Chapter 3: Quality Risk Management (QRM) -- Chapter 4: Technology Transfer Process -- Chapter 5: Scaling-Up of Solid Orals: Granulation, Drying, Size Reduction, Blending, Compression, and Coating Technologies -- Chapter 6: Qualification, Continued Process Verification, and Lifecycle Management -- Chapter 7: Continuous Improvement Case Study: Transforming Legacy Products. |
| Record Nr. | UNINA-9910731465203321 |
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Pazhayattil Ajay Babu
|
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| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2023 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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