PlumGxP published an article examining recent FDA Form 483 observations and the practical steps for 503B facilities to strengthen microbiology and sterility-assurance programs.

PlumGXP provides GMP laboratory testing, environmental monitoring support and practical technical guidance for pharmaceutical and life-science organizations. Our clients understand their regulatory responsibilities. They come to PlumGXP when they need knowledgeable execution, additional laboratory capacity or experienced support with the technical details that can determine whether a program produces meaningful information. We approach every sample with curiosity, discipline and context. A result is more than a number or observation—it is part of a larger story involving the process, facility, sampling method, environment and people behind it. Our capabilities include environmental monitoring qualification and execution, pharmaceutical microbiology, water-system testing, cleaning-validation support, laboratory supplies and consultative GMP support. Whether supporting a defined project, an ongoing testing program or an unexpected technical question, PlumGXP helps clients look beyond the result and make informed, defensible decisions. Located in Allentown, Pennsylvania, and serving pharmaceutical and life-science organizations that value responsive communication, sound science and practical execution. Every sample tells a story. Look beyond the result. To learn more about our services or discuss your organization's needs, send us a message or contact us at contact@plumgxp.com.