Brazil Blazing Trail on Excipient GMPs
This article was originally published in PharmAsia News
Brazil’s ANVISA shows global leadership in regulating pharmaceutical excipients with proposed excipient GMPs. Comments were generally favorable, though there were concerns about the extent of applicability to foreign excipient makers.
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The International Conference on Harmonization strengthens the hand of regulatory authorities in consensus-based discussions with industry, while applauding the growing role of non-ICH authorities in its expert working groups.
Who can coordinate a global response to the pharma supply chain crisis? Industry and regulators debate whether ICH, which smoothed over GMP differences among developed nations, is the right institution for today’s problems, which emanate from non-ICH countries. FDA’s Woodcock describes what the goal should be. IPEC proposes forum to help launch global excipient GMPs. Time is short, with excipient GMPs proliferating in China, Brazil, elsewhere. Support grows for approaching ICH to establish a Q7B guideline for excipients comparable to the Q7A guideline for active ingredients. Big impact expected from Rep. John Dingell’s FDA Globalization Act based on latest discussion draft. Second round of GMP revisions may call for supplier audits, FDA says. IPEC completes excipient qualification guidelines, which set forth process for negotiating quality agreements. The EU advances anti-counterfeiting, regulatory cooperation efforts. Third-party supplier auditing poised for growth.
FDA made request after finding unacceptable levels of nitrosamine NDMA can form during storage above room temperature or beyond expiry. Forthcoming guidance on detecting impurities like nitrosamines in any drug will call for routine testing as well as a chemical risk assessment “to look at what is the probability of generating them.