| Nom | Support | Langue | Disponibilité | Date d'édition | Prix | ||
|---|---|---|---|---|---|---|---|
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PDF sécurisé |
Anglais |
Active |
01/11/2011 |
551,00 € |
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PDF sécurisé |
Anglais |
Active |
01/01/2012 |
433,00 € |
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|
PDF sécurisé |
Anglais |
Active |
01/11/2011 |
551,00 € |
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|
PDF sécurisé |
Anglais |
Active |
01/01/2012 |
433,00 € |
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Détails
Part 2 presents the small molecule case study developed by the ISPE PQLI® teams. This case study provides details of the application of the approaches to product and process understanding using quality risk management. Part 2 also refers to the many case studies in the public domain and uses ICH guidelines Q8 (R2), Q9, Q10, together with other relevant ICH guidelines.
Informations supplémentaires
| Auteur | International Society for Pharmaceutical Engineering |
|---|---|
| Edité par | ISPE |
| Type de document | Guide |
| Thème | /subgroups/37880 |
| EAN ISBN | 9781936379231 |
| Nombre de pages | 232 |
| Mot-clé | ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 2 - Product Realization using QbD, Illustrative Example |
