Search results with tag "Blend uniformity"
THE USE OF STRATIFIED SAMPLING OF BLEND AND DOSAGE …
pqri.orgThis method is used to demonstrate blend uniformity using dosage unit results. For example, a tablet with potency of 19.4 mg and weight 1 The proposals in this document assume that an on-line, in-process measurement system is not currently available for demonstrating blend uniformity (e.g., on-line NIR measurement of in-process blend or dosage
Guidance for Industry - PQRI
pqri.orgNov 06, 2003 · Traditional powder blend sampling and testing, in conjunction with testing for uniformity of content in the finished product, can be used to comply with current good manufacturing practice requirements 2 The FDA wit hdrew t e guidance for industr y ANDAs: Blend Uniformity Analysis on Ma 17, 2002.
THE USE OF STRATIFIED SAMPLING OF BLEND AND …
pqri.orgFinal PQRI Blend Uniformity Working Group Recommendation to FDA December 20, 2002 Page 3 of 15 1. The test should be simple to perform, maximizing the use of …
DRAFT - Product Quality Research Institute
pqri.orgDRAFT Page 5 of 13 further process development exercises should be conducted to address the deficiencies in the blending process. Demonstrating Blend Uniformity…