The ICH has published a Concept Paper on the development of a guideline which would harmonise the limits of metal impurities in the three large economic areas Europe, USA and Japan. For new medicines or drugs that are already marketed in Europe, a document about the limitation of metal impurities already exists, called: „Guideline on the specification limits for residues of metal catalysts or metal reagents" (EMEA/CHMP/SWP/4446/2000). However, this guideline only applies to Europe. Similar guidelines with instructions on the control of metal impurities in the other two geographical regions either do not exist or contain different requirements from the respective national authorities. Yet, as the ICH's mission is to develop harmonised guidelines for the drug and API industry in the three economic areas, it was thus logical to start "Step 1" of the ICH process to face the significant issue of metal impurities.
The Concept Paper called "Q3D: Impurities: Guideline for Metal Impurities" is not already the draft of a guideline, it is first of all a document which justifies the need for such an important and useful regulation. In brief, the justification is based on the following:
The existing Q3A, Q3B and Q3C guidelines have already been integrated into the pharmacopoeial standards. An analogue inclusion of modern analytical standards for the control of metal impurities into the different pharmacopoeias would be a definitely useful complement and a significant progress.
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)