Search results for "CQA"
Article
Going Small to Achieve Success on the Commercial Scale
…acterization of the impacts of different process parameters on product critical quality attributes (CQAs), which in turn necessitates considerable experimentation, according to Meizinger. “While the …
Article
Host-Cell Protein Measurement and Control
The amount of residual HCPs in drug product is generally considered a critical quality attribute (CQA), due to their potential to affect product safety and efficacy. Therefore, it is a regulatory requ…
Article
A Bright Future for the Plasma Fractionation Industry
Philippe Paoloantonnacci presented a QbD approach for a new LFB IVIg product, with identification of Product Quality Attributes (PQAs) and Critical Quality Attributes (CQAs). Process risk analysis was…
Article
Raw Material Variability
Common examples would be out of specification for a product critical quality attribute (CQA), slower cell growth, low titer, and evidence of extraneous matter following visual inspection.
Fixing…
Article
Advancing QbD in the EU
…nce or an "enhanced" structured approach, which involves concepts like critical quality attributes (CQA), design space, and control strategies.
The industry has been urging EU authorities to p…