New White Paper by USP

On 23 September 2009, USP, the American pharmacopoeia, published a white paper with the title "USP's Role in Setting Enforceable Quality Standards for Medicines".

This publication is meant to point out ways of changing the USP further in order to lay down the legal quality standards for medicinal products and to address the present challenges to a "safe global drug supply".

From the USP's point of view, there are in fact deficiencies with regard to USP/NF: It is said that 44% of the USP have deficiencies - on the one hand through a lack of monographs (34%), on the other hand due to monographs that need to be updated (10%). One of the main reasons for this lack of current monographs is the fact that the USP does not get enough support from the pharmaceutical industry in the form of information and materials that it needs for creating monographs.

Therefore, the USP has developed new ways of creating monographs enabling greater flexibility. The examples mentioned are flexible monograph / pending monograph / non-U.S. monograph / performance-based monograph.

According to the USP Convention, major efforts will be necessary to correct all shortcomings. The USP has defined priorities for creating and updating monographs, and together with the industry, it intends to identify those monographs that could have the greatest impact on public health.

Another part of the white paper deals with the activities of the Pharmacopoeial Discussion Group (PDG). One of the statements is that, despite the achieved results, the PDG process remains "slow and laborious"!

And it is mentioned that the USP has increasingly developed a growing understanding for the application of a scientifically based measuring system, today called "metrology", and that these modern concepts are in fact meant to be implemented. These new standards are intended to promote the traceability of analytical results and to improve the consistency and reliability of analytical measurements.

You can find all these contents and some additional points as well if you follow this link: http://www.usp.org/pdf/EN/members/qualityMedicines.pdf

Author.
Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)

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