The requirements of the EU-GMP Guidance Annex 1 "Manufacture of Sterile Medicinal Products", published in 2008, came into force in 2010. In terms of Vial Capping (Chapter "Finishing of sterile products"), there was a need for interpretation. The PIC/S provided the first interpretations with their document PI 032-2 entitled "GMP Annex 1 Revision 2008, Interpretation of most important changes for the manufacture of sterile medicinal products" - see our GMP News from 13. January 2010.
However, other interpretations are possible. A survey about industrial practice for the implementation of those requirements was launched during autumn 2010. Around 230 persons participated.
How do you perform capping?
What is your clean room background for your capping station?
How do you implement "restricted access" to your the capping process?
The complete results of this survey will be presented at the Pharma Congress 2011 which will take place on the 22/23 March 2011 in Düsseldorf.
Dr. Andreas Mangel
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)