PQLI Key Topics - Criticality, Design Space, and Control Strategy

Author:

Garcia Thomas,Cook Graham,Nosal Roger

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmaceutical Science

Reference20 articles.

1. Product quality lifecycle implementation: practical approach to QbD, ISPE Washington Conference, Arlington, VA, 6–7 June, 2007.

2. Product Quality Lifecycle Implementation (PQLI): Practical approach to quality by design, ISPE 2007 Berlin Conference, Berlin, Germany, 19-September-2007.

3. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use, ICH Harmonised Tripartite Guideline, Pharmaceutical Development Q8, Step 4, 10-November-2005.

4. International Conference on Harmonisation, ICH Draft: Step 1, Q8 (R1) Pharmaceutical development revision 1, Step 3, November 2007.

5. International Conference on harmonisation of technical requirements for registration of pharmaceuticals for human use, ICH harmonised tripartite guideline, quality risk management Q9, Step 4, 9-November-2005.

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