European Pharmacopeia Defines Policy for Potentially Genotoxic Impurities

Strasbourg, France (July 1)-The European Pharmacopeia Commission has published the General Information chapter “Potentially Genotoxic Impurities and European Pharmacopoeia Monographs on Substances for Human Use” in the July 2008 edition of PharmEuropa. The chapter defines the policy for dealing with potentially genotoxic impurities (PGIs) while current monographs undergo revision and elaboration.

As the chapter states, this policy concerning PGIs must:

• Take due account of the European Medicines Agency’s Committee for Medicinal Prodcuts (CHMP’s) “Guideline on the limits of genotoxic impurities,“ effective Jan. 2007, which limits retrospective application

• Define clearly the need for control of PGIs in substances described in the new monograph

• Define clearly the application to PGIs in substances described in existing monographs.

In addition, the policy should be reflected in the general monograph “Substances for Pharmaceutical Use (2034), General Chapter 5.10 “Control of impurities in substances for pharmaceutical use,” and the Technical Guide. The policy may also serve as a  basis for assessments in the Certification Procedure.

The chapter provides a table describing the action that substance manufacturers may take in situations such as whether the substance included in a medicinal product was authorized before the issuance of the CHMP guideline and whether there is a PGI expected from the synthetic route. 

Read the complete text of the General Information chapter.