The PharmaTech Talk blog reports more trouble out of China with supplies of crospovidone. It seems the FDA is investigating one lot of Chinese supplied raw material for excessive amounts of peroxide - reportedly found to be 4 times theses maximum allowed level of 400 ppm as recommended in the monographs.
These peroxide levels are not inherently dangerous to human health directly - but as crospovidone is used ubiquitously in many drug formulas - there is fear that elevated peroxide levels could have adverse effects on shelf life of active ingredients resulting in loss of drug potency before expected.
If problems with this Chinese source material are confirmed, this will just be another black eye for raw material suppliers in this area of the world given previous problems with heparin and melamine. Go to the blog link above for further links to FDA site on this topic.
Also, you may be interested in searching this blog for addtional posts on the SAFC raw material characterization program. We have established enhanced analytical and biological testing regimes to better characterize all our raw materials going into cell culture medium - for example - that support biopharmaceutical manufacturing. Examples are here, here and here - but there are more. There are also links to a couple of interviews on supply chain integrity and supporting quality systems - one from me and one from our VP of Quality and Regulatory Affairs, Tom Beil.
Posted by Bruce Lehr October 23rd 2010.
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