As a result of legislation passed by the European Parliament and in cooperation with the European Commission, changes have been made to the EU Guide on Variations to Marketing Authorizations. “The purpose of the changes that will be introduced with the implementation of the revised Variation Regulation is to simplify the procedure and at the same time assure patient safety and product quality,” said EMEA representative Riccardo Luigetti.
“Rapid Microbiology Methods have reached a mature state as technology. They can be essential in building and maintaining appropriate sterility assurance levels in sterile manufacturing processes. However, it is disappointing to see, how few sites in Europe have actually implemented such technologies, although they are relatively easy to establish,” said Paul Hargreaves, GMP inspector at the UK Medicines and Healthcare products Regulatory Agency.
www.pda.org/europe