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
Water for Injection (EDQM)
Further to these discussions and to determine whether or not the problems/issues listed in this reflection paper are still valid, the European Pharmacopoeia Commission during its 135th session requested the EDQM to follow-up this issue. To this end, the EDQM has initiated a survey through industry associations to gather suitable information and data. The outcome of this survey and subsequent evaluation will further determine whether or not the monograph included in the European Pharmacopoeia dealing with WFI (Ph. Eur. 0169) should be amended to consider RO as a possible alternative. The list of points addressed in the survey is directly linked to those listed in the above mentioned reflection paper.
Outcome:
Return the filled in survey and supportive data until May 30, 2010. Manufacturers are encouraged to channel their answers through the association they belong to.
Links:
EDQM/ Announcement
EMA/ Reflection Paper