Tracking Environmental Monitoring Trends Crucial to Regulatory Compliance, OsoBio Expert Says
Albuquerque, NM Jul 28, 2011 – A microbiology laboratory manager at OSO BioPharmaceuticals Manufacturing, LLC, has authored a chapter on environmental monitoring trends for an industry reference manual.
Kim Van Antwerpen wrote a chapter for “Environmental Monitoring: A Comprehensive Handbook (vol. 5)” edited by Jeanne Moldenhauer and being published in September by the Parenteral Drug Association.
Van Antwerpen’s key observation is that aseptic drug manufacturers should closely observe the environmental monitoring trends of their production facilities to ensure regulatory compliance and protect consumer health.
OsoBio, an injectables CMO, manufactures sterile liquid, suspended and lyophilized biologic and pharmaceutical products for the pharmaceutical industry. The company is known for its expertise in difficult–to–manufacture, demanding or highly potent products.
In her chapter, Van Antwerpen wrote that each aseptic drug manufacturer should have a clear understanding of its unique environmental monitoring profile in order to pro–actively execute preventive or corrective steps if an adverse trend is detected.
“The manner in which data are trended influences all stakeholders – both internal and external – and affects resulting opinions of one’s environmental monitoring program, perceptions of control at the production facility, and actions taken to mitigate potential risks,” she stated. “When trends are presented in a concise, thorough and understandable manner, the company gains credibility.”
Van Antwerpen will be a featured speaker at the PDA’s sixth annual Global Conference on Pharmaceutical Microbiology, taking place Oct. 17–19 in Bethesda, Md. She will discuss how to trend environmental data using commonly available software presentation, as well as how best to implement an environmental review board.
Van Antwerpen holds a bachelor’s of science degree in microbiology from the University of Wisconsin–La Crosse and a master’s degree in business administration from the University of Phoenix. A Lean Six Sigma black belt, Van Antwerpen is a member of the Parenteral Drug Association – for which she serves on its program steering committee – and a senior member of the American Society for Quality.