Cross-contamination is a major concern within the pharma manufacturing industry, particularly for products produced at multi-product or shared facilities, such as contract manufacturing organizations (CMOs). In fact, if you outsource production to a CMO, your Quality Agreement should address cross-contamination prevention

Under GMP requirements, pharma manufacturers must ensure adequate measures to prevent cross-contamination, the transfer of a harmful substance from one surface to another. In the United States, 21 CFR 211 includes a section that requires companies to institute facility controls

Check out some articles addressing cross-contamination written by our Senior GMP Quality Expert Jerry Chapman.

[Related: Click here to request a FREE 483 Observation Report on human drug GMP 483 observations involving facilities and equipment.]

483 observations specific topic

Get a Demo

We’ll can show you insights into any of your key suppliers, FDA investigators, inspection trends, and much more.

Request a Demo