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
21.10.2026EMA Updates Information Page on Bioequivalence Guidelines
21.10.2026BP Publishes new Draft Texts
21.10.2026FDA Identifies Critical Deficiencies in Analytical Testing and CGMP Oversight
07.10.2026Analytical Quality Group Developments May through August 2026
07.10.2026Two New FDA Warning Letters Put OOS Investigations in Focus
07.10.2026Pharmeuropa: Revision Proposed for Chapter 2.5.32 on Coulometric Karl Fischer Water Determination