As described by the FDA, stability testing provides evidence of the effect of time and environmental factors on the quality of pharmaceuticals and medicinal products. Such factors include light, humidity and temperature. Stability tests also establish a re-test period for the drug substance or a shelf life for the medicinal product along with recommended storage conditions.
Stability tests are conducted in validated stability chambers such as manufactured by Norlake for pharmaceutical (ICH), biological (BOD), scientific and laboratory applications. These tests, which subject the product samples to variations in temperature and humidity, are conducted during drug product development as well as once a candidate drug reaches use and are governed by current good manufacturing practices (cGMPs). They are regulated in the U.S. by 21 CFR Part 211 Section 166. (www.gmp1st.com/drreg.htm#211.166)
While these tests are conducted in stability test chambers, it is not simply a matter of buying a chamber and plugging … Read the rest