Implications and opportunities of applying QbD principles to analytical measurements

Pharmaceutical Technology

Volumn 34, Issue 2, 2010, Pages 52-59

  Schweitzer, Mark ^a,b   Pohl, Matthias ^c,d   Hanna Brown, Melissa ^e   Nethercote, Phil ^f   Borman, Phil ^f   Hansen, Gordon ^g   Smith, Kevin ^e   Larew, Jaqueline ^e   Carolan, John ^h   Ermer, Joachim ⁱ   Faulkner, Pat ^e   Finkler, Christof ^e   Gill, Imogen ^e   Grosche, Oliver ^e   Hoffmann, Jörg ^j   Lenhart, Alexander ^a   Rignall, Andy ^k   Sokoliess, Torsten ^l   Wegener, Guido ^m  

^a ABBOTT LABORATORIES   (United States)

^b Pharmaceutical Research and Manufacturers of America (PhRMA)   (Switzerland)

^c NOVARTIS PHARMA AG   (Switzerland)

^d Topic Team   (Switzerland)

^e GlaxoSmithKline ^*

^f GLAXOSMITHKLINE   (Australia)

^g Boehringer Ingelheim   (Australia)

^h MERCK RESEARCH LABORATORIES   (United States)

ⁱ Sanofi aventis   (Australia)

^j MERCK KGAA   (Germany)

^k ASTRAZENECA   (United Kingdom)

^l Boehrlnger Ingelheim   (Canada)

^m BAYER CORPORATION   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

DRUG PRODUCTS; MEDICINE;

ANALYTICAL METHOD; CONTINUOUS IMPROVEMENTS; PHARMACEUTICAL MANUFACTURERS; PHARMACEUTICAL PRODUCTS; PRODUCT DEVELOPMENT ACTIVITIES; QUALITY BY DESIGNS; REGULATORY AGENCIES;

PRODUCT DESIGN;

DRUG INDUSTRY; DRUG MANUFACTURE; DRUG QUALITY; MEASUREMENT; QUALITY CONTROL; REVIEW;

EID: 77950677448     PISSN: 15432521     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (2)

1. P. Borman et al., Pharm. Technol., 31 (12), 142-152 (2007).
2. USP Ad Hoc Advisory Panel on Inorganic Impurities and Heavy Metals, Stimuli paper (2008), www.usp. org/pdf/EN/USPNF/2008-04- 0InorganicImpuritiesStim.pdf.