USP and BPC harmonize first finished product monographs

By Gareth Macdonald

- Last updated on GMT

USP and BPC harmonize first finished product monographs
Drug manufacturers will benefit from harmonisation of finished product monographs says the USP after a first of its kind collaboration with the BPC.

The United States Pharmacopeial Convention (USP) and the British Pharmacopoeia Commission (BPC) developed monographs for two prescription eye medications (accessible here​ and here​ with free login), which will be included in the organisations’ respective pharmacopeias.

USP chief science officer Praveen Tyle told “These newly proposed monographs are the first drug products that have been harmonized prospectively between USP and BP.  In fact, they are the first drug products to be prospectively harmonized between USP and any other pharmacopeia.

Tyle explained that the informal collaboration involved an exchange of information on topics like identification and impurity detection to ensure that monograph development was consistent across both organisations which - he believes - is an approach that could be applied more widely.

This type of activity is one we would absolutely be open to engaging in with other pharmacopeias as well as BP​,” he said, adding “we engage in international cooperation on many different levels, and experimenting with this informal approach is just another vehicle. The informal nature of the partnership here might provide a more nimble path forward in many cases​.”

Manufacturer benefits

The USP is also confident that greater harmonization of monographs – both as a result of the latest collaboration and other ongoing efforts - will help pharmaceutical manufacturers, as Tyle explained.

The benefits of this initiative are similar to the benefits of any harmonization activity—less burden on manufacturers in complying with multiple, different pharmacopeial requirements by country, which also preserves resources​.”

He also said such work provides manufacturers with a more streamlined submission process, citing the two new finished product monographs as an example.

For these two monographs, the manufacturer sent a single submission to both USP and BP at the same time and questions were shared so that the need for multiple instances of communication was minimized.”

Beyond this Tyle said that consistent quality expectations across borders – developed as a result of information shared by experts from different regions - will make for more consistent and safer global drug supplies.

The USP also wants manufactures’ input on future harmonization projects - particularly for finished product monographs – according to Tyle, who explained that such feedback is a key driver.

At present, we don’t have other finished products that we are targeting. This is in part dependent on industry engagement in the process. We hope manufacturers will submit monographs to us that might be the subject of future informal harmonization activities.”

Related topics: Regulations, Regulatory & Safety

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