|Articles|April 2, 2019

USP

USP’s Ingredient Verification Program for Excipients includes a complete evaluation of your quality system.

USP’s Ingredient Verification Program for Excipients includes a complete evaluation of your quality system. We take a holistic approach to excipient quality, incorporating a thorough review of your manufacturing batch records and product release data and offering an in-depth examination of how quality decisions affect your final product.

 

USP
12601 Twinbrook Parkway, Rockville, MD 20852
tel. +1.301.881.0666
CPhI North America Booth #2330


Related to this article

Glass vial, pipette and woman scientist in laboratory for medical study, research or experiment. Test tube, dropper and professional female person with chemical liquid for pharmaceutical innovation. | Image Credit: ©HockleyMedia24/peopleimages.com -stock.adobe.com
Equivalence test using two one-sided tests are widely used for demonstrating the comparability of treatment effects in different research fields. The method described in the manuscript aims to use simulations in Microsoft Excel to compute power for 2 one-sided tests for two groups with unequal variances.
Complying with International Pharmacopoeias
Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, with Parexel, clear up some of the confusion about what does and does not need to be complied with regarding standards set by international pharmacopoeias.