‘Outsourcing' of Inspection Functions by Glp Compliance Monitoring Authorities

This document is a statement of policy set by the 1989 Council Decision-Recommendation on Compliance with Good Laboratory Practice [C(89)87(Final). It reiterates the decisions and the recommendations related to the role and responsibilities of governments, national GLP compliance monitoring authorities and inspectors set out in that Act and its Annexes and states current practices. The Working Group on GLP

is of the opinion that, while the Council Act allows “outsourcing” of inspection functions, this should be the exception rather than the rule and should be used only as an interim solution and primarily by new GLP compliance monitoring programmes.