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
NEW FDA Risk Guidance
This guideline is not relevant for the GMP related areas but it covers a lot of quality and security topics within the submission process. If you are in charge of this areas this draft guidance may be interesting for you.
Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said to this guidance: “With this new guidance, manufacturers will have a useful blueprint for how to develop these important safety strategies.”