Stability testing guidance gets stickier
Executive Summary
FDA's 1revised guidance on stability testing of drug products raises the relative humidity recommendation for "general case" intermediate storage from 60% to 65%. The change "is intended to harmonize the intermediate storage condition for [climatic] zones I and II with the long-term condition for zones III and IV," FDA says. The Pharmaceutical Research & Manufacturers of America had been pressing for the modification to the 2001 guidance (2"The Pink Sheet" Jan. 6, 2003, p. 20)...