Brazil Blazing Trail on Excipient GMPs
This article was originally published in The Gold Sheet
Executive Summary
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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China is imposing tougher – and in some cases unrealistic – requirements for excipient manufacturers, while Brazil is proposing similar new requirements. Confusion abounds with respect to shelf life, expiration dates and retest dates.