Creating quality by design/process analytical technology (QbD/PAT) management awareness

Pharmaceutical Engineering

Volumn 28, Issue 3, 2008, Pages 36-38

  Woelbeling, Christian ^a  

^a Werum Software and Systems AG   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

AWARENESS; DOCUMENTATION; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG QUALITY; GOOD MANUFACTURING PRACTICE; PROCESS CONTROL; QUALITY CONTROL; REVIEW; TECHNOLOGY; VALIDATION STUDY;

EID: 45249124065     PISSN: 02738139     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (2)

1. ISPE Affiliate Germany/Austria/Switzerland Regional PAT COP, "Creating QbD/PAT Management Awareness" document, September 2007.
2. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Quality and Manufacturing Guidelines Q8 (Pharmaceutical Development), Q9 (Quality Risk Management), and Q10 draft (Pharmaceutical Quality System).