US Pharmacopoeia makes standards public

The United States Pharmacopoeia (USP) today announced the availability of free and online collection of voluntary public standards for testing of a medicine and its ingredients.

The USP wishes to help ensure that medicines and their ingredients used around the world are of good quality. These standards appear in the new USP Medicines Compendium, a press release said.

The first group of standards posted on its website on Friday includes those for anti-malarial, anti-retroviral (HIV) and contraceptive medicines among others.

“Public standards help ensure that all manufacturers of a given medicine or ingredient meet the same fundamental requirements, providing a ‘common ground’ that allows practitioners to have confidence in the medicines they prescribe, and patients in the medicines they take. Thee standards are critical-especially where regulatory resources are constrained or absent,” said Roger L Williams, chief executive officer of USP.

MC will support good quality medicines through tests, procedures, and acceptance criteria for critical quality attributes, the release said. These standards are voluntary, unless they are adopted by a regulatory authority and are intended to support the text and work of other pharmacopeias, it said.

USP has its presence in Hyderabad, which boasts a number of homegrown pharmaceutical companies, including Dr Reddy’s. It recently built its own premises housing laboratory facilities, by far the largest outside the US.