An FDA/ISPE partnership aimed at applying science- and risk-based principles to multi-product facilities is expected to bear fruit in the next few months. The Baseline Guide for Risk-MaPP aims to provide manufacturers with a template for managing the risk of product cross-contamination within facilities.
Among the document's lead authors is consultant Stephanie Wilkins of PharmaConsult US. She notes in PharmaQbD that "run of the mill ordinary compounds are not being controlled very well." That may be because they pose little threat to equipment operators. Such compounds often are processed in open equipment and with lax contamination control procedures. "These are possibly the most likely compounds to cross-contaminate other products," according to the publication.
Given the global marketplace, an increasing number of drug manufacturers don't understand the hazards of the products they are producing, Wilkins says.
She adds that some big pharma manufacturers are very likely working on the details of their quality risk management plans that address cross-contamination. "We have members on our team from AstraZeneca, GSK, J&J, Merck, Pfizer and sanofi-aventis. I would suspect they have been working with their firms to implement Risk-MaPP principles."
- see the interview