Since International Conference on Harmonisation (ICH) Q8, Q9 and Q10 were finalised industry has sought clarification. The latest answer adopted by the US Food and Drug Administration (FDA) covers the need to evaluate the outer limits of design space during process validation at commercial scale.
“There is no need to run the qualification batches at the outer limits of the design space during process validation studies at commercial scale. The design space should be sufficiently explored earlier during development studies”, the FDA states in guidance released this month.
Adding the answer brings the total number of design space responses in the document up to nine. Previous answers have confirmed design space applies to scale-up, site change and formulation.
FDA adoption of the revised question and answer document comes 11 months after the European Medicines Agency (EMA) released its updated version and a year after the answer was approved.
Barcode requirements
The FDA is also seeking comments on the use of barcodes as part of a retrospective review of current regulations. In March 2003 the FDA published a proposed rule for using linear barcodes to cut medication errors but since then alternative technologies have improved.
Advances mean technology can now identify, validate, authenticate, and track and trace drugs. The FDA has separate guidance on using standardised numerical identifiers (SNIs) but raises the topic as “the same technology may be used for both purposes”.
To investigate convergence of the tasks the FDA asks if anyone has used linear bar codes for track and trace. If not, the FDA wants to hear about technologies that can cut medication errors while performing other roles.