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.
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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
EDQM: Related Substances
In European Pharmacopoeia monographs, the acceptance criteria for related substances have so far usually been expressed in terms of comparison of peak areas (“… not more than the area of the principal peak in the chromatogram obtained with reference solution …”), which, strictly speaking, leads to a pass/fail decision but not to a true quantitative test result.
Outcome:
Send your comments to the appropriate national pharmacopoeia authority. Readers from countries that are not members of the European Pharmacopoeia Commission should send their comments directly to the European Directorate for the Quality of Medicines and HealthCare (EDQM). Comments on this proposal should be submitted by 30 May 2010.