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: Working Plan 2010 of QWP
Among other Activities the Quality Working Party will contribute to development and implementation of applicable (V)ICH guidelines, as mentioned in paragraph IV.
- Contribution to the development of the ICH Q11 guideline on development and manufacture of the active substance;
- Contribution to the implementation in the EU of ICH Q8 (Pharmaceutical Development), Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality Systems);
- Contribution to the discussion on Common technical document (ICH topic M4);
- Contribution to the development, review and update of other ICH Quality Guidelines, as requested.
Outcome:
Check the complete Work Plan, if you are interessted in ongoing development!
Link:
EMA/ Work Plan