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USA: FDA Drafts Guidance on Post-approval Manufacturing Changes for Biologics

Thursday, August 10, 2017: As the number of chemistry, manufacturing and controls (CMC) post-approval manufacturing supplements continues to increase, the US Food and Drug Administration (FDA) released draft guidance offering recommendations for holders of biologics license applications (BLAs) on the types of minor changes to be documented in an annual report.

"Under FDA regulations, post-approval changes in the product, production process, quality controls, equipment, facilities, or responsible personnel that have a minimal potential to have an adverse effect on product quality must be documented by applicants in an annual report," the agency says (italics are FDA's).

If a manufacturing change is considered "major," an applicant must submit and receive FDA approval of a BLA supplement (also known as a prior approval supplement) before the product produced with the manufacturing change is distributed.

If a change is considered "moderate," an applicant must submit a supplement at least 30 days before the product is distributed (known as a CBE-30 supplement) or in some cases, the product may be distributed immediately upon FDA's receipt of the supplement (known as a CBE-0 supplement).

And if changes are considered "minor," an applicant just has to notify FDA of the change in an annual report. However, FDA adds, "For any change, applicants must assess the effects of the change on product quality through appropriate studies."

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