January 25, 2012
Manufacturers of sterile drug products are confronted with increasing quality standards to produce defect-free products, reduce process/product variation, and minimize product rejects. Parenteral drug products intended for injection must meet requirements set forth in the United States Pharmacopeia (USP) Chapter <1> Injections, including the following specifications regarding foreign and particulate matter:
“Each final container of all parenteral preparations shall be inspected to the extent possible for the presence of observable foreign and particulate matter … in its contents. The inspection process shall be designed and qualified to ensure that every lot of all parenteral preparations is essentially free from visible particulates.”1
Particulate matter in finished pharmaceuticals can come from multiple sources, such as the ingredients in the drug product, processing equipment, or the container closure system. Manufacturers of sterile drug products should consider a means to reduce or exclude particulate matter and container closure defects in products.2
1. U.S. Pharmacopeia. USP 34–NF 29 General chapter <1> Injections, labeling of ferrules and cap overseals section. Aug. 4, 2010. USP website. Available at: www.usp.org/USPNF/notices/ferrulesCapOverseals.html. Accessed Nov. 22, 2011.
2. U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research. Center for Biologics Evaluation and Research. Office of Regulatory Affairs. Guidance for industry: Sterile drug products produced by aseptic processing – current good manufacturing practice. September 2004. Available at: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070342.pdf. Accessed Nov. 22, 2011.