Current Events in Blend and Content Uniformity

Reprinted from PHARMACEUTICAL ENGINEERING. THE OFFICIAL TECHNICAL MAGAZINE OF ISPE. MARCH/APRIL 2014, VOL 34, NO 2. product development Copyright ISPE 2014. Stratified Sampling Current Events in Blend and Content Uniformity by James S. Bergum, PhD, James K. Prescott, Ravindra W. Tejwani, Thomas P. Garcia, PhD, Jon Clark, and William Brown This article presents a summary of the stratified sampling session held at the 2013 ISPE Annual Meeting. I n 1999, the Product Quality Research Institute (PQRI) provide a summary of that session. Note that some presenta- established the Blend Uniformity Working Group. The tions are not summarized here, in cases where permissions purpose of this group was to make scientifically based for publication were not granted. recommendations on suitable procedures to ensure Blend and Content Uniformity of a batch. The recom- Basis for the Withdrawal of the Draft mendation had to comply with 21 CFR Sampling Guidance Document and Testing of In-Process Materials and Drug Prod- The primary reason for the withdrawal of the draft guidance ucts,1 which require in-process testing for adequacy document was that Sections V and VII no longer represent of of mix.

PHARMACEUTICAL ENGINEERING MARCH/APRIL 2014 1 produt development Stratified Sampling Current Events in Blend and Content Uniformity by James S. Bergum, PhD, James K. Prescott, Ravindra W. Tejwani,

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  Current, Content, Uniformity, In blend and content uniformity, Blend

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