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.]
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