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How gravimetric sample preparation is helping pharmaceutical manufacturers meet the demands of consumers, regulators, and the market


Jun 10 2021
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Since the groundbreaking Barr Labs case in 1993, the FDA has issued hundreds of observations concerning poor handling of out-of-specification (OOS) investigations, necessitating untold hours of lab effort as well as significant fines. Today, gravimetric sample preparation is giving pharmaceutical companies around the world a cost-effective way to avoid OOS errors, which in turn is helping them to reduce the occurrence of time-wasting investigations, enhance productivity and safety, and save costs.
From the number of warning letters issued periodically by the US Food and Drug Administration (FDA), it is apparent that OOS results are more common in pharmaceutical manufacturing than they should be. These errors not only result in time-consuming internal investigations and fines. Depending on an error’s extent and market visibility, it can also make a significant impact on a pharmaceutical company’s reputatio ....

States Pharmacopeia , Drug Administration , Barr Labs , Time Savings , United States Pharmacopeia , மாநிலங்களில் மருந்தகம் , பார் ஆய்வகங்கள் , நேரம் சேமிப்பு , ஒன்றுபட்டது மாநிலங்களில் மருந்தகம் ,