A pharma manufacturer's view of quality by design: Pfizer's experience with QbD

Pharmaceutical Technology

Volumn 35, Issue 8 SUPPL. 1, 2011, Pages

  McCurdy, Vince ^a   Migliaccio, Gerry ^a   Nosal, Roger ^a   Spavins, James ^a  

^a PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG QUALITY; PROCESS DESIGN; PRODUCT SAFETY; QUALITY CONTROL; TOTAL QUALITY MANAGEMENT;

EID: 80051915128     PISSN: 15432521     EISSN: 21507376     Source Type: Journal    
DOI: None     Document Type: Article

References (4)

1. FDA, "Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality of Assessment System; Notice of Pilot Program, " Fed. Reg. 70 (134), 407619-40720 (July 2005).
2. ICH, Q8 Pharmaceutical Development (2008)
3. ICH, Q9 Quality Risk Management (2005).
4. ICH, Q10 Pharmaceutical Quality Systems (2008).