FDA's Office of Generic Drugs revised the guidance for industry on impurities in active pharmaceutical ingredients in generics in June 2009. The guideline applies to active ingredients manufactured by chemical synthesis. Find more here.
The ASTM-document (formerly American Society for Testing and Materials) 2500-07 offers modern aspects regarding equipment qualification. A comparison shows differences to the classical way of DQ, IQ, OQ, PQ. Read more.
An implementation report on the 'Transatlantic Administrative Simplification Action Plan' has been published. This report is a result of the recent annual EU-EMEA/ FDA bilateral meeting in September, where the parties updated on the progress and status of the various projects. Read more.
Since December 2006, the Regulation (EC) No 1901/2006 on Medicinal Products for Paediatric Use is in operation. And this regulation is mandatory for all pharmaceutical companies developing new products! Read more about the consequences for Pharmaceutical Development.
During the recent annual EU-EMEA/FDA bilateral meeting in September 2009, the parties updated on the progress of several projects, among others on the Collaboration on inspections. You will find more here
Dr Janice M. Soreth, Deputy Director of the Europe/US FDA, Liaison to EMEA, located in London, U.K. has accepted the invitation of the QP Association to talk about the international programs of the FDA at the 4th QP Forum. Read more.