Freigaberelevante Prüfungen von Arzneimitteln durch Auftragslaboratorien
Unter besonderer Berücksichtigung der aktuellen Anforderungen in der 15. AMG-Novelle
Dr. Frank Böttcher
Labor L+S AG, Bad Bocklet-Großenbrach
Pharmaceutical companies assign tests to contract service laboratories for various reasons. The placing can occur in scope of research projects or for release tests of approved products if, for example, specific tests are required for which the pharmaceutical company itself is not equipped, is unwilling to set up or to carry it out for reasons of costs. Publications show mainly articles concerning outsourcing of tests which deal with supplier ratings and auditing. In the following, the reciprocal relation between customer and the laboratory is pointed out in respect of the release-testing of pharmaceuticals and in particular often occurring problems faced by the contract service provider. In this regard the contract service providers without manufacturing license according to § 13 AMG are supposed to stand in the focus since this often concerns providers of specific test procedures. Besides a change occurred in the 15th amendment of the German drug law (AMG) in § 13. An admission is destined for tests which are relevant for release of medicinal products as well. The regulation to assign release tests partially according to § 14 (4) AMG to institutes without permission is maintained. Therefore the changes of the former regulations should be discussed here.