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Audits by independent experts promise to ease the burden that customer audits can have on suppliers, while ensuring drug manufacturers that ingredients meet strict cGMP standards.
Today, a growing number of compliance and quality failures can be traced to problems with API and excipient manufacturing. Finished drug manufacturers must be sure that the ingredients used in their products meet current good manufacturing standards, but the expense and time required for audits can be a significant burden. From the ingredient supplier’s perspective as well, having pharmaceutical customers conduct thorough audits of their facilities can pose serious challenges. One solution that the world’s regulatory agencies are supporting is having experts from independent authorities conduct these audits and provide certificates of compliance.
Sessions at CPhI will discuss pharmaceutical and raw material quality in great depth from Oct. 9–11, 2018 in Madrid, Spain. For more information on third-party inspection and certification, this article from Pharmaceutical Technology’sSeptember supplement on pharmaceutical materials, written by experts affiliated with the International Pharmaceutical Excipients Council (IPEC) outlines how the practice works, what is required, and the benefits it offers (1).
1. D.B. Klug, R.D. Lindblad, D.G. Muse, K. L. Ulman, P. Walsh, and P.S. Zawislak, Pharmaceutical Technology APIs, Excipients, & Manufacturing 2018 (September 2018).