Although methods for detection exist and might be practical for periodic screening, FDA expects that manufacturers prevent such contamination through adherence to CGMPs. A CGMP-compliant quality system will ensure that assurances are obtained suppliers and that measures are taken to prevent exposure to problematic compounds. Manufacturers of finished pharmaceuticals are reminded that the CGMP regulations at 21 CFR 211.56(c) require written procedures for sanitation designed to prevent the contamination of equipment, components, drug product containers, closures, packaging, labeling materials, and drug products. Analogous recommendations for manufacturers of active pharmaceutical ingredients are included in internationally harmonized (European Union, Japan, United States) ICH guidance for industry Q7 Good Manufacturing Guidance for Active Pharmaceutical Ingredients (section 4.7).
