title: The use of stratefied sampling of blend and dosage units to demonstrate adequacy of mix for powder blends.
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). 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.
authors.affiliation: Faulding, Inc.
authors.forename: Garth
authors.initials: G
authors.lastname: Boehm
authors.forename: Jon
authors.initials: J
authors.lastname: Clark
authors.forename: John
authors.initials: J
authors.lastname: Dietrick
authors.forename: Laura
authors.initials: L
authors.lastname: Foust
authors.forename: Thomas
authors.initials: T
authors.lastname: Garcia
authors.forename: Muralidhara
authors.initials: M
authors.lastname: Gavini
authors.forename: Loren
authors.initials: L
authors.lastname: Gelber
authors.forename: Jean-Marie
authors.initials: JM
authors.lastname: Geoffroy
authors.forename: Jack
authors.initials: J
authors.lastname: Hoblitzell
authors.forename: Pedro
authors.initials: P
authors.lastname: Jimenez
authors.forename: Gerald
authors.initials: G
authors.lastname: Mergen
authors.forename: Fernando
authors.initials: F
authors.lastname: Muzzio
authors.forename: Jerry
authors.initials: J
authors.lastname: Planchard
authors.forename: James
authors.initials: J
authors.lastname: Prescott
authors.forename: Jozef
authors.initials: J
authors.lastname: Timmermans
authors.forename: Neeru
authors.initials: N
authors.lastname: Takiar
mesh_terms: D002626:Chemistry, Pharmaceutical; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000592:standards; D017408:Guidelines as Topic; D011208:Powders / Q000737:chemistry / Q000592:standards*; D011786:Quality Control; D018401:Sample Size; D013678:Technology, Pharmaceutical / Q000331:legislation & jurisprudence / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D011208:Powders