PQLI Application of Science- and Risk-based Approaches (ICH Q8, Q9, and Q10) to Existing Products

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.

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Pharmaceutical Quality System Q10, Step 4, 4-June-2008.

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Pharmaceutical Development Q8 (R1), Step 4, November 2008.

Nosal R, Schultz T. PQLI Definition of Criticality. J Pharm Innov 2008;3:69–78.

Lepore J, Spavins J. PQLI Design Space. J Pharm Innov 2008;3:79–87.

Davis B, Lundsberg L, Cook G. PQLI Control Strategy Model and Concepts. J Pharm Innov 2008;3:95–104.

Final Business Plan, Q10: Pharmaceutical Quality Systems dated 14 October 2005

Metamorphosis of Manufacturing, from Art to Science, IBM Consulting, May 2005

EC Draft Variations Regulations and Public Consultation Paper Version: 24 October 2007 ( http://ec.europa.eu/enterprise/pharmaceuticals/varreg/index.htm )

Procedure for Worksharing—Quality variations. EMEA/120457/2006, June 2006

Reflection Paper: Chemical, pharmaceutical and biological information to be included in dossiers when Process Analytical Technology (PAT) is employed. EMEA/INS/277260/2005.

Guidance for Industry PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, September 2004

CPMP/QWP/3015/99, Parametric Release, February 2001