PQLI control strategy model and concepts

Journal of Pharmaceutical Innovation

Volumn 3, Issue 2, 2008, Pages 95-104

  Davis, Bruce ^a   Lundsberg, Line ^b   Cook, Graham ^c  

^a ASTRAZENECA   (United Kingdom)

^b NNE Pharmaplan   (Denmark)

^c Wyeth Pharmaceuticals   (United Kingdom)

Author keywords

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

Indexed keywords

DRUG;

ARTICLE; CONTROL STRATEGY; DRUG FORMULATION; DRUG MANUFACTURE; DRUG PACKAGING; DRUG QUALITY; GOOD MANUFACTURING PRACTICE; INTERNATIONAL CONFERENCE ON HARMONIZATION; NEAR INFRARED SPECTROSCOPY; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROCESS CONTROL; PROCESS DEVELOPMENT; QUALITY CONTROL; RISK ASSESSMENT;

EID: 44649123593     PISSN: 18725120     EISSN: None     Source Type: Journal    
DOI: 10.1007/s12247-008-9035-1     Document Type: Article

References (16)

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15. PQLI Key Topics - Criticality, Design Space and Control Strategy DOI 10.1007/s12247-008-9032-4
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