PDA Midwest Dinner Meeting

Performance Validation sponsored and exhibited at the PDA Midwest Dinner Meeting. In attendance from PV were Mike Stires and Gerry Achoki.

The speaker for this event was Tony Cundell, Ph.D. who presented on Current Activities of the USP General Chapters – Microbiology Expert Committee.

Mr. Cundell gave an overview of United States Pharmacopeia’s mission, role, international recognition, and described the content and generation of the USP Documentary Standard (USP40/NF35). He then spoke specifically about the make-up and work being performed by the Microbiology Expert Committee, of which he is a member.

Some of the highlights of Mr. Cundell’s presentation include a new proposal for a Sterility Assurance chapter, an area that the Microbiology Expert Committee believed lacked guidance. The chapter will provide a general description of the concepts and principles involved in the preparation of articles that must be sterile. Mr. Cundell discussed a new chapter proposal for Guidelines on Endotoxin Tests to fill the gap created by the retirement of the FDA’s 1987 Endotoxin Guideline. Mr. Cundell also discussed the development of USP guidance in the area of Rapid Sterility Testing. He mentioned that the USP has received feedback that current USP growth-based sterility testing guidance, with at least 14 day incubation, does not meet the needs of stakeholders who manufacture, test, and release short-lived cell-based biologicals, sterile compounded and Positron Emission Tomography (PET) injectable products. He also strongly encouraged participation in the Pharmacopeial Forum which is published to provide an opportunity for public review of, and comment on, revision activities affecting the U.S. Pharmacopeia and the National Formulary, expressing that the Forum is a very important tool that the expert committees review in order to receive feedback from industry.

Source: Cundell, T. (2018). Current Activities of the USP General Chapters – Microbiology Expert Committee [PowerPoint]. Retrieved from http://www.pdamidwest.org/images/presentations/Feb.2018/CundellUSPMicrobiologyExpertCommittee15Feb2018.pdf