Never ever a 483?
We can not promise that you will never get a 483
but we know that the GMP MANUAL includes all
procedures and processes you need to be
GMP compliant.
Newsletter registration
PDA Parenterals Conference
From 26-28 October, 2010 the PDA Parenterals Conference will be held in Berlin.
This outstanding event will cover the very important topics:
- Future of Parenterals
- Packaging and Impact on Quality
- Manufacturing Flexibility and Control
- Innovative Plants
- Monitoring Technologies
- Medical and Application Devices
- Regulatory Trends
Don´t miss this interesting conference in Berlin, Germany.
News about GMP/cGMP
Quality by Design - Regulators Opinion
As we noticed in several presentations through the last time QbD is getting more and more important.
QbD supports
- knowledge improvement
- process understanding
- improvement of manufacturing performance
- compliance improvement
- patients safety
All recent presentations demonstrates more openness to a dialog with the industry. QbD has also impact on inspections and this need training and time to change the inspection systems from system-based inspections to process quality related inspection.
We are convinced that we are on the right way with that kind of discussions.
See more detailed interpretation in the link below to the presentation of David Cockburn.
EMEA/Efpia presentation: Regulators Perspective on "Quality by Design"
Source: EMEA website