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Blend Uniformity and Content Uniformity (BUCU) Milestones
- The Team has submitted two manuscripts for peer review and is awaiting comments:
- Recommendations for the Assessment of Blend and Content Uniformity. Part 1: Modifications to Withdrawn FDA Draft Stratified Sampling Guidance
- Recommendations for the Assessment of Blend and Content Uniformity. Part 2: Technical Discussion of Sampling Plans and Application of ASTM E2709/E2810.
- Once the manuscripts are accepted for publication, they will be shared with other health authorities.
- The Group has offered to assist health authorities on the concepts in their papers.
- The Group will write a third manuscript that will discuss how the recommendation can be implemented into practice, would be valuable to the industry and regulators. It will educate and market the approach and explain the meaning of 50% coverage and other issues brought up during the June 2-3 ISPE/FDA CGMP conference.
- A member of the BUCU Team will present the current recommendations from the group at the 2014 AAPS Annual Meeting and Exposition (2-6 November 2014, San Diego, CA).
- Members of the BUCU Team have been invited by the USP to advise on the preparation of the new chapter (USP<1905>) outlining the sampling considerations for batch release.