EMA Proposes Update to Sterile GMP Regulations
European sterile drug makers will have to implement ICH Q9 and ICH Q10 under a new EMA proposal.
The EMA issued the proposal to bring good manufacturing practices for sterile drug makers in line with GMPs other manufacturers follow.
The agency wants comments on the proposal outlining the change by March 31.
The next steps for the proposal call for the GMP/Good Distribution Practices Inspectors Working Group and the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme Committee to review comments this summer.
The groups plan to submit draft guidance in October with comments due in April 2016. A final guidance could be completed by July 2016.
Poor microbial contamination control is now a top Form 483 observation. The focus to date has been on compounding pharmacies, but no FDA- or EU-regulated manufacturer is exempt from purity laws. Now’s the time for a hard look at your production processes with Manufacturing Sterile Products to Meet EU and FDA Guidelines.