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.

• FDA on Cross-Contamination, Sustainable Compliance, and Contract Ops
  Learn more about specific cross-contamination issues FDA investigators are finding during inspections.
• Case Study of Contaminated WFI in China
  Find out how a major pharma company addressed cross-contamination issues at a CMO site in another country.
• Cleaning and Cross-Contamination Issues with an Encapsulator
  An FDA investigator explains what led to cross-contamination issues at a large, global manufacturer of tablets and capsules.

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