Good Manufacturing Practice Inspection in Europe,in Light of the New Central Agency and Current International Agreements

Abstract

This paper covers good manufacturing practice (GMP) inspection in Europe. Inspections within the European Union and in other countries are discussed. Excerpts of Council Regulation No. (EEC) 2309/93 are provided. Topics covered include coordination of inspections, supervisory authority, the Pharmaceutical Inspection Convention, mutual recognition with other countries, and more.