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
EMA: Biopharmaceutical and Bioanalytical Data
The development of this guidance will result in improved data presentation in the MAA dossier thus facilitating the regulatory review process. In addition, it would potentially support applicants in the identification of any gaps in their datasets. The primary focus would be on applications for generic medicinal products although the principle can also be applied to any other application where such data is presented.
Outcome:
Deadline for Comments: July 31, 2010. Comments should be provided using the template liked to the document. The comments form should be sent to ewpsecretariat@ema.europa.eu.
Link:
EMA/ Concept Paper