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Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL:
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FDA’s Guidance on Out-of-Specification Results has been seen as the state of the art regarding the handling of OOS results. In the meantime, Europe – through the British MHRA and the German ZLG – has also developed requirements on that topic. Read more here about the most important regulations of the respective guidance documents.
GMP News: Handling of OOS Results in Europe
http://www.gmp-compliance.org/enews_4461_Handling-of-OOS-Results-in-Europe_8360,8430,Z-QCM_n.html
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