Results of the Survey "Implementation of the new Annex 1 requirements for Capping"
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?
- 44 % undertake capping as an aseptic process with sterilized caps inside the aseptic core.
- 56 % undertake it as a "clean process" outside the aseptic core.
What is your clean room background for your capping station?
- 17% said Grade B
- 39 % - Grade C
- 37 % - Grade D
- 7 % answered "miscellaneous" (Grade E/F or another one).
How do you implement "restricted access" to your the capping process?
- 23% answered a RABS (Restricted Access Barrier Systems - with gloves)
- 7% said an isolator.
- 54% have a safety cabinet.
- 16% answered "miscellaneous".
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.
Author:
Dr. Andreas Mangel
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
Literature:
EU-GMP Guidelines Annex 1
PIC/S PI 032-2