USP and FDA strengthen Collaboration
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In Mai 2011, the USP announced that they will continue and expand their collaboration with the FDA.
A 3-year agreement was signed to support the development of USP written and physical reference standards.
Around 40 chemical reference standards are concerned and should be jointly controlled by USP and FDA laboratories. Moreover, joint work to modernize tests and assays in USP’s written, or documentary, standards should be promoted and test methods for hand-held instruments that inspectors can use to screen drugs in the field for adulteration, contamination and authenticity should be developed further.
Due to the new challenges by falsified medicinal products, which can result in deadly medicine, it is necessary to have quality standards that reflect the current state of science and technology and not older methodologies.
Over the last years, hand-held detection technologies have made huge advances. For this reason, the FDA plans to use them in the search for counterfeit medicines.
The complete
USP - Document can be found here.Author:
Günter Brendelberger
CONCEPT HEIDELBERG
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