PQLI design space

Journal of Pharmaceutical Innovation

Volumn 3, Issue 2, 2008, Pages 79-87

  Lepore, John ^a   Spavins, James ^b  

^a MERCK RESEARCH LABORATORIES   (United States)

^b PFIZER INC   (United States)

Author keywords

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

Indexed keywords

DRUG;

ARTICLE; CHIRALITY; CONTROL STRATEGY; DRUG CLASSIFICATION; DRUG EFFICACY; DRUG GRANULATION; DRUG MANUFACTURE; DRUG SAFETY; DRUG STABILITY; GOOD MANUFACTURING PRACTICE; INTERNATIONNAL CONFERENCE ON HARMONIZATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROCESS CONTROL; PROCESS DESIGN; PROCESS DEVELOPMENT; QUALITY CONTROL; RISK ASSESSMENT; SHEAR RATE; TABLET COMPRESSION;

EID: 44649092655     PISSN: 18725120     EISSN: None     Source Type: Journal    
DOI: 10.1007/s12247-008-9034-2     Document Type: Article

References (7)

1. 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.
2. PQLI Key Topics - Criticality, Design Space and Control Strategy DOI 10.1007/s12247-008-9032-4.
3. 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.
4. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Pharmaceutical Quality System Q10, Step 2, 9-May-2007.
5. Procedures for Performing a Failure Mode, Effects and Criticality Analysis, United States Military Procedure MIL-P-1629, 9-November-1949.
6. EMEA PAT Team Position Paper, http://www.emea.europa.eu/Inspections/docs/ PATGuidance.pdf.
7. Criticality in PQLI DOI 10.1007/s12247-008-9033-3.