The United States Pharmacopeia (USP) guidelines mandate that laboratory staff must undergo specific training curricula and should not conduct microbial tests independently until they are qualified. Similarly, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) advises that sterility testing be performed only by personnel who have been trained, qualified, and certified, with periodic recertification recommended.

This training program provides a thorough review of the essential regulatory requirements for sterility testing, covering risk mitigation, sterility test methods, necessary consumables, and result interpretation. The content draws from the established standards of the United States Pharmacopeia (USP) and the European Pharmacopeia (EP).

sterility test

Speaker: Ms. Samatchaya Vitoorapakorn (สมัชญาวิทูรปกรณ์) Regional Regional Commercial Application Expert – SEA BioM Merck Ltd.