European Regulatory Standards

The article on the CPhI conference in Paris discusses the oversight of Good Manufacturing Practices compliance in Europe and states, "The responsibility still falls solely on drug company quality control staff to ensure that any APIs they use are made in compliance" (C&EN, Oct. 23, 2006, page 41).

This statement is not entirely true. While most European states did not set up inspection schemes for active substance manufacturing sites, some countries have chosen to implement different regulations on the national level as long as they fulfill the requirements of the supranational European Union guidelines as a minimum level.

The Republic of Austria, for instance, has chosen to implement the regulations of the ICH Q7A guideline, which regulates drug substance manufacture in such a way that the manufacturing sites of drug substances are subject to an identical approval, inspection, and change-control scheme as the manufacturing sites of drug products.

Despite attempts for harmonized regulations within the EU, national implementations may differ, making general statements on the EU difficult.

Michael M. Bobek
Austria