Drugs

New CDER Biologics Compliance Program Explained

The 4/14 CDER Compliance Program 7346.832M, “Prelicense and Preapproval Inspections of CDER-Regulated Biological Product Manufacturers,” which takes effect 5/14, provides a long-awaited framework and clarifies how FDA will evaluate commercial readiness, application commitments, CGMP compliance, and data integrity for both 351(a) and 351(k) BLAs. That’s the conclusion of attorneys Cathy Burgess and Yifan Wang (Alston & Bird) in an online post analyzing the new compliance program.

Highlights of the program are:

FDA will use a single inspection framework across standalone and biosimilar BLAs;
inspections will be led by the Office of Pharmaceutical Quality and integrated into the BLA review process; and
FDA will use a risk-based approach to determine when inspections or alternative tools are appropriate to support product approval.

The new compliance program distinguishes between pre-license inspections (PLIs) and pre-approval inspections (PAIs) this way, the attorneys say:

a PLI is an inspection of a facility that manufactures a new biological product subject to an original BLA;
a PAI is an inspection of a facility that manufactures a licensed biological product for which the applicant has submitted a supplement for a significant manufacturing change, such as a prior-approval supplement, that requires on-site review.

The attorneys say the new program describes a risk-based approach to determining whether a PLI or PAI is necessary, based on:

the manufacturing operations described in the application;
prior inspection history;
prior assessment of the same or similar operations;
product and process complexity; and
quality signals.

FDA identifies two primary objectives for PLIs and PAIs, the post says:

to evaluate and verify application commitments and compliance with applicable CGMP requirements; and
to evaluate the integrity of the data associated with the application.

The attorneys recommend that BLA applicants submit a manufacturing schedule with the BLA and ensure consistency in inspection responses.

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