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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
FDA: Q4B, Annex 10
This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions.
Annex 7 and 9 were published on April 2, 2010 by the FDA. Read the News concerning these two Annexes.
Outcome:
The ICH Steering Committee, based on the evaluation by the Q4B Expert Working Group (EWG), recommends that the official pharmacopoeial texts, the section in Ph. Eur. 2.2.31. Electrophoresis entitled Sodium Dodecyl Sulphate Polyacrylamide Gel Electrophoresis (SDSPAGE), JP General Information 23. SDS-Polyacrylamide Gel Electrophoresis, and USP <1056> Biotechnology-derived Articles – Polyacrylamide Gel Electrophoresis, can be used as interchangeable in the ICH regions.
Links:
FDA/ Annex 10
GMP-Publishing/ Annex 7 & 9