Microtest Laboratories has posted a white paper on its website to help personal care product manufacturers understand microbial limits testing policies in accordance with the harmonization of the United States Pharmacopeia (USP), European Pharmacopeia (EP) and Japanese Pharmacopeia (JP) requirements.
On May 1, 2009, the harmonized test methods became effective, requiring manufacturers to meet new guidelines. The new methods have new techniques, media, incubation times and incubation temperatures. Products previously validated under earlier methods, therefore, may need to be re-evaluated.
"USP Microbial Examination of Non-Sterile Products: A Roadmap to the Regulations of the Non-Sterile Testing World" reportedly 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.
The paper examines: the affects of harmonization, sample requirements, sample processing, suitability testing vs. validation and essential product information required for testing.
