Industry Reacts to Tough Excipient Regulations in China and Brazil
This article was originally published in PharmAsia News
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.
You may also be interested in...
Brazil Blazing Trail on Excipient GMPs
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.
Program Participants Urge The FDA To Adopt Some Pharmaceutical Quality Metrics And Avoid Others
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”
EU GMP Annex I Is A Top Priority For EMA While Industry Has Lingering Concerns
Questions about contamination control strategy raised as European Medicines Agency makes EU GMP Annex I revision a top priority in its 2021 work plan.