News & Publications
Keep up to date with PharmaConsult Us. News about PharmaConsult Us, Regulatory Issues and upcoming events are listed below. Find articles authored by PharmaConsult Us in the "By Us" section of the page.
Our First Podcast!
Listen to our first podcast. Stephanie Wilkins is interviewed by Dean Calhoun of Affygility Solutions on Risk-MaPP, ADEs and PDEs: Their importance to multi-product pharmaceutical manufacturing.
Stephanie will be running the ISPE Risk-MaPP training course in Tampa December 3-4, 2014. Come learn how to set up a risk management program for the risk of cross contamination. For more information click here.
Julian Wilkins presented "Case Studies in Making Risk Assessments Meaningful" at Interphex on March 18, 2014.
Stephanie Wilkins presented "Using Shared Facilities for Manufacturing High Potency Finished Drugs" at Interphex on March 18, 2014. To see the presentation click here.
QR Consult Us Release
PharmaConsult US announces the release of QR Consult US a cloud based system used to assist in managing the risk of cross contamination. The system helps to identify worst case products in a facility, cleaning limits between the various products, what products share which equipment and much more.
For more information click here.
PharmaConsult Us developed a Gowing Module designed for shared/ multiproduct facilities where the process room is negative to the corridor, there are no airlocks; gowning is undertaken centrally and the corridor is common to rooms processing different compounds.
In gathering data on the potential for cross contamination it became clear that in many cases operators were not only traversing corridors in API soiled gowning, but were able to work on several products without a gown change. Such practices are capable of cross contamination to the limit particularly when at the single dosage scale. In existing unit operation type facilities, using the Gowning Module means that operators can safely gown and de-gown at the process room boundary and not tracking API through the common areas of the facility.
Controlling cross-contamination is not all about putting compounds in dedicated facilities, there is more to it than that. Learn more by reading "Are You Controlling Your Boundary"
Controversary on the use of health-based limits - learn why you should use them. Click here and here
How do you use health-based limits to manage the risk of cross-contamination? Learn more by reading "The Use of ADEs for Managing the Risk of Cross-Contamination in Pharmaceutical Manufacturing"
For some basic information on managing the risk of cross-contamination and Risk-MaPP read this article "Risk-MaPP: Managing the Risk of Cross-Contamination" from IPT's December 2010 issue, http://www.iptonline.com.
See results from a cross-contamination study in "A Quantitative Study in Cross Contamination".
Want to learn about ADE's? Check out this presentation "ADEs and their importance".