We provide consultancy on all aspects of the aseptic and sterile production as well as on compliance testing. Our services cover aseptic practices, training, investigations, site inspection preparations and proposal for GMP solutions.
The manufacture of sterile products is subject to special and high standard requirements in order to minimile risks of particulate , microbiological contamination and pyrogen contamination. Standards required by Regulators have increased significantly within last 20 years. In order to protect aseptic processes, industry has progressively replaced the conventional aseptic rooms grade A/B by isolators and RABS ( Restricted Access Barrier Systems ). The number of RABS has progressed from 75 in 2005 to 378 in 2011 and the number of isolators for filling purpose has increased from 84 in 1998 to 427 in 2010 in the world. Conventional aseptic rooms grade A/B will be more and more challenged by FDA and EMA inspectors.
Based on 13 years experience in parenterals and more than 80 GMP audits of sterile facilities, we provide support in compliance with the current regulations, and in particular :
- Annex 1 of Eudralex ( directive 2003/94/EC ) for Europe.
- US Guidance - sterile drug products produce by aseptic processing - current good manufacturing practice.
- ISO 13408, 14644 and 14698 norms, etc ...