Industry Reacts to Tough Excipient Regulations in China and Brazil
This article was originally published in The Gold Sheet
Executive Summary
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.
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ICH association convenes; ISO revises cleanroom standards; NSF accredited for excipient GMP certification; supply chain library launched.
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