THE EU IS ASSESSING ITS API QUALITY INITIATIVES to see how they are working in practice. An inspection survey of finished product manufacturers in the EU shows general compliance with the new expectations for supplier auditing and supply chain traceability. The European API industry, however, continues to lobby for more foreign inspection coverage to reflect the risks and level the GMP playing field. A new GMP database is part of an EMEA effort to strengthen compliance information sharing within and outside the EU. The European Directorate for the Quality of Medicines & HealthCare, meanwhile, is also analyzing the API inspection and review results from its Certificate of Suitability (CEP) program and finding that genotoxic impurities and starting materials are frequent filing problem areas. A fast-tracked EC proposal for overhauling the variations regulatory approach is now out for comment, drawing a very welcome reception, although EU’s API industry notes its change problems are not directly addressed. At a recent meeting in Yokohama, Japan, ICH advanced the new Q8-10 quality regulatory paradigm by agreeing to pursue drug substance guidance, forming an implementation working group, and moving forward a Q8 annex to deepen quality-by-design understanding. While focusing on its own API regulatory controls, the EU is also joining with the U.S. in supporting efforts by China to strengthen its quality regulatory system in view of the Western model, which include tightening its GMP certification standards.
CONTENTS:
3……Viracept recall Implicates API GMPs
5……New Genotoxic, REACH rules in EU
6……EMEA To Issue GMP Guide rewrite
7……EU States Vary In API Inspecting
8……EudraGMP database Established
11….EdQM reports on API Inspections
11….CEP Problems Analyzed By EDQM
22….EC Proposes Variations overhaul
23….Key Items Include EU Harmonization
25….Harmonized Variations List With U.S.?
25….Impact on API Changes At Issue
33….Audit Programs Are ramping Up
34….ICH Targets APIs, Implementation
35….China Strengthening API oversight
37….GMP Certificate Bar Raised
38….Chinese GMPs do Not Equal Q7A
39….China’s Steps Include “Green GDP”
