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PQRI Stratified Sampling Approach To Drug Uniformity Endorsed By Cmte

Executive Summary

Stratified sampling and in-process dosage unit testing should be allowed in lieu of blend sampling to demonstrate drug blend uniformity during routine batch production, FDA's Pharmaceutical Science Advisory Committee concluded at its May 8 meeting

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Blend uniformity guidance withdrawn May 6 due to "scientific issues relating to the scope of the guidance and methodology for blend uniformity analysis in general," FDA said. Product Quality Research Institute's stratified sampling approach was endorsed by FDA's Pharmaceutical Science Advisory Committee (1"The Pink Sheet" May 13, p. 25). FDA will issue a revised guidance following evaluation of the PQRI proposal. Companies must still "monitor and validate the performance of processes that could be responsible for [product] variability, including adequacy of mixing," FDA noted. The guidance, "ANDAs: Blend Uniformity Analysis," was issued in 1999...

Blend uniformity guidance withdrawn

Blend uniformity guidance withdrawn May 6 due to "scientific issues relating to the scope of the guidance and methodology for blend uniformity analysis in general," FDA said. Product Quality Research Institute's stratified sampling approach was endorsed by FDA's Pharmaceutical Science Advisory Committee (1"The Pink Sheet" May 13, p. 25). FDA will issue a revised guidance following evaluation of the PQRI proposal. Companies must still "monitor and validate the performance of processes that could be responsible for [product] variability, including adequacy of mixing," FDA noted. The guidance, "ANDAs: Blend Uniformity Analysis," was issued in 1999...

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