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
Part III of the EU GMP Guide planed
The Site Master File concept has been developed by PIC/S and has become a standard expectation of EU authorities. Following a recent revision of the explanatory notes by PIC/S, it has been proposed that the status of the Site Master File is more formally linked to the EU regulatory framework.
It is proposed that a new informational Part III of the EU GMP Guide is created for documents which are not themselves GMP guidelines and have no statutory force but which complement the GMP guidelines and related regulatory procedures such as, in this case, inspections.
It is expected that in the future, further documents will be added to the new Part III and that such documents would be included following public consultation.
The document is identical to the content of the Site Master File by PIC/S and is published in parallel.
Outcome
If you are interested in commenting the draft document, send your comments by 31 March 2010 to entr-gmp@ec.europa.eu and ADM-GMDP@ema.europa.eu.
If you are not interested in commenting, you can wait until the final version will be published.
Link