USP and FDA strengthen Collaboration
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
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
Related GMP News
18.12.2025FDA Form 483: Excel-Based Data Falsification and Duplicate Log Books
18.12.2025Questions and Answers on System Suitability Tests (SST) - Part 1
18.12.2025PharmaLab 2025: Brief Summary of AQCG Track - Save the Date for 2026!
18.12.2025FDA Warning Letter: 1,500 OOS Results with Numerous Inadequate Investigations
17.12.2025FDA Warning Letter Criticises Handling of OOS Results at a Contract Laboratory
17.12.2025FDA Warning: No Recall Conducted Despite Confirmed Benzene Impurity