Myth:
Quality systems do not apply to biologics or medical devices.
Reality:
With regard to inspections from a US perspective, Q10 applies equally to drugs, biologics, and new products. It is not applicable
to device inspections, however, it serves to make the approaches more parallel. —J.C.F.
Myth:
My company has not caught up with Q8 or Q9, we can't possibly start implementing Q10.
Reality:
While Q8, Q9, and Q10 are intended to be a trilogy, it is possible to implement Q10 without having implemented Q8 (i.e., a
company could decide not to adopt quality-by-design [QbD] but to still have a modern, effective quality system with management
commitment to quality, policies for risk management, and oversight of outsourcing activities and knowledge management, CAPA,
etc). Looking ahead, Q11 Development and Manufacture of Drug Substances, has entered the harmonization process. Q11 is an "enabler" for Q8 Pharmaceutical Development. If active pharmaceutical ingredient manufacturers do not adopt QbD, it is going to be almost impossible for the drug product
manufacturer to do so. —K.G.
Source: The above questions and responses were compiled from the June 2008 Quality Systems in a Global Market webcast (4)
as well as from questions posed to the webcast panelists after the event.
For more on this topic, see
All Roads Now Lead to Quality Systems
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