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GMP proposal does not require routine blend testing, FDAer tells NDMA seminar.

This article was originally published in The Tan Sheet

Executive Summary

FDA GMP PROPOSAL DOES NOT REQUIRE ROUTINE BLEND TESTING as a regular in-process step, FDA Philadelphia. District Director Diana Kolaitis clarified during the Nonprescription Drug Manufacturers Association's annual Manufacturing Controls Seminar Oct. 10-11 in Philadelphia. In response to NDMA's Oct. 8 comments on the proposed GMP reg, Kolaitis stated that the "proposal does not imply that we expect to see blend testing as a matter of routine once the process has, in fact, been validated."





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