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Blend Uniformity Analysis: FDA and Industry at Crossroads over PQRI Conference

Strategic Insights

— 1 min read

The Product Quality Research Institute (PQRI) is set to host a critical conference in September, where the first major dispute between FDA and the regulated industry over blend uniformity analysis (BUA) will take center stage. The August 1999 draft guidance on BUA has triggered concerns among industry stakeholders, who fear that the prescriptive criteria for acceptance may be too stringent and could lead to a host of issues, including the potential requirement for BUA on every batch. The conference will bring together industry representatives, including Aventis, Bayer Consumer Care, and Glaxo-Wellcome, as well as FDA officials and academics, to devise a compromise or research program on the matter.

Key Takeaways:

  • The Product Quality Research Institute (PQRI) conference in September will address the first major dispute between FDA and the regulated industry over blend uniformity analysis (BUA).
  • The August 1999 draft guidance on BUA has established prescriptive criteria for acceptance, including mean values of 90-110% and relative standard deviations of 5% or less.
  • Industry stakeholders, including Big Pharma companies, fear that the draft guidance may lead to a host of issues, such as the potential requirement for BUA on every batch.
  • Representatives from Duramed, FDA, and various universities will join industry speakers to discuss key topics, including powder blending, acceptance criteria, data analysis, and regulatory questions.
  • The conference will focus on devising a compromise or research program on the issue of BUA in submissions, including whether it should be required for ANDAs and NDA'd drugs.

Statistics:

  • 90-110%: The mean values for acceptance criteria established in the August 1999 draft guidance on BUA.
  • 5% or less: The relative standard deviations for acceptance criteria established in the August 1999 draft guidance on BUA.
  • September 7-8, 1999: The dates of the PQRI conference where the BUA dispute will be addressed.

Sources:

  • "PQRI to Address BUA Dispute" [Source removed for security reason as the request was to show external sources and not internal document links]
  • PDA's annual meeting in Washington last November, 1999
  • FDA's August 1999 draft guidance on BUA
  • www.PQRI.org

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