As more and more tidbits about Johnson & Johnson’s product recall crisis fill the news waves, concerns over supply-chain security and drug safety are rising yet again. Consumers, not to mention Congress, have not forgotten contamination issues with toothpaste, pet food, infant formula, heparin—the list goes on—and the pharmaceutical industry has been pounded with questions about how it’s managing its manufacturing process as well as how it’s monitoring its supply and distribution channels. There should be light at the end of the tunnel given the numerous efforts made by standard-setting and regulatory bodies on this issue.
With regard to melamine contamination specifically, FDA jumped to issue a new guidance in August 2009 on Pharmaceutical Components at Risk for Melamine Contamination, which addresses the use of methods such as LC-MS/MS and GS-MS. The new guidance asks manufacturers to test at-risk components (i.e., ingredients or raw materials that rely on a test for nitrogen content for identity, purity or strength). Also in 2009, FDA issued a Draft Guidance for Industry: Incorporation of Physical Chemical Identifiers (PCIDs) into Solid Oral Dosage Form Drug Products for Anticounterfeiting.
The International Pharmaceutical Excipients Council (IPEC), along with PhRMA, GPhA, CHPA, and SOCMA, launched a coalition to monitor melamine adulteration and is working closely with the US Pharmacopeia to look at monographs and testing. Meanwhile, USP has been meeting with industry and regulators regarding the use of infrared spectroscopy in tandem with gel permeation chromatograph for excipient analysis, which should help check for melamine contamination. There are still some differences, however, among regional pharmacopeias when it comes to testing requirements.
To discuss these updates and what they mean for industry, Pharmaceutical Technology is hosting and SGS Life Science Services is sponsoring a free webinar on the subject on June 29. On the panel will be FDA’s Dr. Steven Wolfgang from the Recall and Shortages Branch, FDA’s Brian Hasselbalch from the Division of Manufacturing and Product Quality, and Dave Schoneker, representing IPEC and global regulatory affairs for Colorcon.