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
Annex 6 EU GMP Guideline published
The Annex was revised as a consequence of the restructuring of the GMP Guide and the need to modify the requirements of Part II of the Guide for applicability to medicinal gases. There was a need to define more clearly what should be considered as a starting material as opposed to a bulk pharmaceutical product. The opportunity was also been taken to update the annex in general.
Link
EC/ Annex 6