USP Microbial Examination of Non-Sterile Products A Roadmap to the Regulations of the Non-Sterile Testing World

A white paper by James E.T. Gebo, B.S., M.P.A., RM (NRCM) and Kimberly Kitch, A.S. of Accuratus Lab Services.

Many health and personal care products released to the market, such as over the counter medicines, creams, and supplements, are not required to be sterile. The microbial quality of these products is ensured because manufacturers are required to evaluate their microbial content. To accomplish this, microbial examination of non-sterile products (microbial limits testing) is performed.

On May 1, 2009, the harmonized test method became effective, requiring manufacturers to meet new guidelines. This paper examines how the recent harmonization of the USP, EP, and JP requirements affects the manufacturers’ processing of raw materials and finished products. It also reviews some of the considerations a manufacturer should examine when establishing a microbial limits testing policy.