【讨论】QBD新法规

The Quality by Design(QbD) concept has been introduced by the International Conference onHarmonisation (ICH) document Q8, supported by Q9, Q10 and also Q11. Inthe meantime it is well-known within the pharmaceutical industry. However manycompanies still struggle with the implementation. Both the European MedicineAgency (EMA) and the U.S. Food and Drug Agency (FDA) are supporting thepharmaceutical industry in the employment of the paradigm. Now, EMA and FDAhave published a second joint question-and-answer document that providesfurther guidance on the quality-by-design concept.
The new document focuseson 'design space verification' and reflects conclusions reached in the on-goingparallel assessment, which was launched in 2011. The objective of the parallelassessment is to share knowledge, facilitate a consistent implementation of theinternational guidelines on the implementation of the quality-by-design conceptand promote the availability of medicines of consistent quality throughout theEuropean Union (EU) and the USA.
The EMA and the US FDAwill publish further conclusions on other quality-by-design-related topics asthe pilot programme continues and more parallel assessments are conducted.