Ph. Eur. to revise monographs for genotoxic impurities

By Nick Taylor

- Last updated on GMT

Related tags: Chondroitin sulfate

The new guidelines for how monographs will be revised and
elaborated to tackle potentially genotoxic impurities (PGIs) have
been published by the European Pharmacopeia Commission.

These policy outlines will be taken upon board upon revision of the Technical Guide as the Pharmacopeia seeks to allay concerns over the presence of PGIs in active substances. At present Ph. Eur. believes that there is "rarely adequate control via the test or tests for impurities​" and is seeking to add an extra level of safety to medicinal products. The Committee for Medicinal Products for Human Use (CHMP) brought in the Guideline on the limits of genotoxic impurities​ at the start of 2007 and this is to be taken into account when the Pharmacopeia forms its new policy. ​A clear definition of the "need for control of PGIs in substances described in new monographs​" is to be brought in by Ph. Eur., as is clarification of how the policy will affect existing monographs. Action will be taken to revise the monographs of substances which were authorised prior to issuance of CHMP's guidelines in several circumstances, based around the expectation that a PGI is present. If a PGI showing genotoxicity is expected to be found in a product authorised prior to CHMP's guidelines the Pharmacopeia has stated the monograph should be revised. There is also the possibility that if a new synthetic route is used for creation of a substance approved after the CHMP guidelines further evaluation of potential PGIs would be necessary. Revision is also deemed necessary if subsequently authorised products based upon the innovator product are expected to contain the PGI at a higher level or contain a new PGI. This piecemeal approach to applying the extra level of safety is deliberate, with Ph. Eur. believing that blanket implementation would hinder the availability of medicines. The full policy document can be found here​. New heparin monographs adopted ​Meanwhile, the Pharmacopeia has also approved new monographs for heparin sodium and calcium as it seeks to prevent a repeat of the crisis that rocked the US when it was discovered that heparin contaminated with oversulphated chondroitin sulphate (OSCS) had been linked to a number of deaths among patients. Approval of the new monographs, which have been amended to hike the level of testing needed for quality control, was granted late last month, with the implementation date scheduled for 1 August. However, this could change pending a decision by the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH). The details of the new monographs can be found here​ and here​.

Related topics: Markets & Regulations, QA/QC

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