The Use of Stratefied Sampling of Blend and Dosage Units to Demonstrate Adequacy of Mix for Powder Blends¹

Abstract

In response to concerns expressed by applicants regarding inconsistent policies in establishing blend uniformity acceptance criteria to demonstrate adequacy of mix, the FDA Office of Generic Drugs (OGD) issued the draft document Guidance for Industry, ANDAs: Blend Uniformity Analysis (August 1999)². Both generic and innovator pharmaceutical companies raised a number of concerns following the publication of this document. As a result, the Product Quality Research Institute (PQRI) Blend Uniformity Working Group (BUWG) was established in February 2000. One of the primary goals of this group was to draft a scientifically based alternative to the OGD document. The resulting recommendation addresses both FDA and industry concerns by substantially enhancing product quality assurance without increasing regulatory burden. The PQRI BUWG recommends that these blend and dosage unit uniformity requirements be administered uniformly throughout the industry. PQRI submitted the following recommendation to the FDA on December 31, 2002, providing the Agency with an alternative strategy to consider when drafting future regulatory policy to assess blend and dosage unit uniformity.