| Name | Support | Language | Availability | Edition date | Price | ||
|---|---|---|---|---|---|---|---|
|
PDF sécurisé |
English |
Active |
11/1/2011 |
€551.00 |
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|
PDF sécurisé |
English |
Active |
1/1/2012 |
€433.00 |
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|
PDF sécurisé |
English |
Active |
11/1/2011 |
€551.00 |
|
||
|
PDF sécurisé |
English |
Active |
1/1/2012 |
€433.00 |
|
||
Details
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.
Additional Info
| Author | International Society for Pharmaceutical Engineering |
|---|---|
| Published by | ISPE |
| Document type | Guide |
| Theme | /subgroups/37880 |
| EAN ISBN | 9781936379231 |
| Number of pages | 232 |
| Keyword | ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 2 - Product Realization using QbD, Illustrative Example |
