Fixing the Negative Perception of QbD
‘Quality by design’ has been around for years, but still the benefits are hardly leveraged in medicine manufacture. I firmly believe that knowledge management can help.
Christoph Herwig |
Quality by design (QbD), which has been with us for decades, is defined by the International Society for Pharmaceutical Engineering (ISPE) as a “systematic approach to development that begins with predefined objectives and emphasizes product and process understanding based on sound science and quality risk management”. The main principles have been assembled by the International Conference on Harmonization (ICH), as laid down in well-known guidelines.
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