PQLI application of science- and risk-based approaches (ICH Q8, Q9, and Q10) to existing products

Journal of Pharmaceutical Innovation

Volumn 4, Issue 1, 2009, Pages 4-23

  Potter, Chris J ^a  

^a NONE   (United Kingdom)

Author keywords

Control strategy; Critical process parameter; Critical quality attribute; Criticality; Design space; Pharmaceutical target product profile; PQLI; Product and process knowledge; Quality by design; Quality risk management

Indexed keywords

ARTICLE; AUTOCLAVE; BIOTECHNOLOGY; COMMERCIAL PHENOMENA; COMPUTER PROGRAM; DRUG GRANULATION; DRUG MANUFACTURE; PHARMACEUTICAL ENGINEERING; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL; RISK ASSESSMENT; RISK MANAGEMENT; TOTAL QUALITY MANAGEMENT;

EID: 63949085904     PISSN: 18725120     EISSN: None     Source Type: Journal    
DOI: 10.1007/s12247-009-9051-9     Document Type: Article

References (13)

1. 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.
2. 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.
3. 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.
4. Nosal R, Schultz T. PQLI Definition of Criticality. J Pharm Innov 2008;3:69-78.
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6. Davis B, Lundsberg L, Cook G. PQLI Control Strategy Model and Concepts. J Pharm Innov 2008;3:95-104.
7. Final Business Plan, Q10: Pharmaceutical Quality Systems dated 14 October 2005
8. Metamorphosis of Manufacturing, from Art to Science, IBM Consulting, May 2005
9. EC Draft Variations Regulations and Public Consultation Paper Version: 24 October 2007 (http://ec.europa.eu/enterprise/pharmaceuticals/varreg/ index.htm)
10. Procedure for Worksharing - Quality variations. EMEA/120457/2006, June 2006
11. Reflection Paper: Chemical, pharmaceutical and biological information to be included in dossiers when Process Analytical Technology (PAT) is employed. EMEA/INS/277260/2005.
12. Guidance for Industry PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, September 2004
13. CPMP/QWP/3015/99, Parametric Release, February 2001