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
EMEA Announced New Guidelines
- Annex 17 Real Time Release Testing shall be changes to facilitate the RTR approach
- There shall be implemented a part III to meet the requirements of Quality Risk Management
- The requirements concerning the content of a Site Master File shall be published for public comments in the near future
- The Good Distribution Practice Guideline will be reviewed
- There are discussions with the PharmEU to change the technical requirements for the production of Water for Injections. Probably reverse osmose will be allowed in the future
The integration of Q8/Q9/Q10 requires the review of several sections in the EU-GMP-Guide. This review phase will take some time even if the changes are more editorial changes.
We will inform you as soon as further information are available.
Source: PDA/EMEA Joint Conference, October 13-14, 2009