PDA Letter Article

Revised USP Micro Chapters Address Changing Technologies

by David Hussong, PhD, Eagle Analytical Services, Radhakrishna Tirumalai, PhD, USP, Edward Tidswell, PhD, Merck, and Donald Singer, GSK

As technological advancements around microbiological testing continue to grow within the pharmaceutical industry, USP’s Microbiology Expert Committee seeks to update some of its microbiology chapters. For each five-year cycle, the Expert Committee has an established workplan intended to help meet USP’s standards-setting goals. Some of the workplan’s major initiatives in the current USP cycle (2015–2020) include sterilization processes and sterility assurance, parametric release, depyrogenation, endotoxin testing, rapid sterility testing of short-life products and a test for the presence of Burkholderia cepacia complex.