The US Food and Drug Administration’s (FDA) last week released a final guidance to assist the pharmaceutical industry in submitting comparability protocols for postapproval manufacturing changes.
The final guidance contains several changes from the draft version issued in April 2016. (RELATED: Postapproval CMC Changes: FDA Updates Guidance, Regulatory Focus 19 April 2016)
Among the changes are the incorporation of the International Council on Harmonisation (ICH) Q12 principles for postapproval changes, allowing manufacturers to change API suppliers though the use of a comparability protocol instead of requesting this change through the more burdensome prior approval supplement (PAS) reporting category and expanding the scope of the guidance to address CPs for drug master files (DMFs) and drug-device combination products.
The final guidance defines a comparability protocol as a “comprehensive plan, prospectively written plan for assessing the effect of a proposed postapproval CMC change(s) on the identity, strength, quality, purity and potency of a drug product, including a biological product.” The protocol may be submitted as part of the original application or in a PAS…
