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Endotoxin Testing Comports With QbD as Part of Risk Management Plan: Guidance
Drugmakers keen to infuse quality by design (QbD) concepts into regulatory filings are urged to fold endotoxin testing into their overall risk-management plans, an FDA draft guidance states. The QbD strategy for endotoxins testing should also be based on product and process understanding, the agency said in the recently posted question-and-answer guidance.
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