The cannabis market has been rapidly growing with the list of identified cannabinoids constantly increasing. Analytical methods for detecting cannabinoids by means of HPLC (High Pressure Liquid ...

In the past 10 years, the pharmaceutical industry has been moving towards a design space approach to development and manufacture – an approach that has been defined by ICHQ8, Q9 and Q10, and the ...

Analytical Quality by Design (AQbD) principles call for a deeper, more systematic understanding of all factors that influence the performance of analytical procedures in quality control. By embedding ...

With the publication of ICH Q2(R2) and ICH Q14, the modern Quality by Design (QbD) paradigm introduced by ICH Q8 for manufacturing has now been extended to Quality Control (QC). A life cycle and ...

Bioprocessing emerged from a history of extensive testing for quality assurance, but some of that is changing. Instead of an industry built on quality by testing (QbT), bioprocessing would benefit ...