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
WHO: New Technical Report published
WHO has published seven adopted annexes:
Annex 1: WHO good practices for pharmaceutical quality control laboratories
Annex 2: WHO good manufacturing practices for active pharmaceutical ingredients
Annex 3: WHO good manufacturing practices for pharmaceutical products containing hazardous substances
Annex 4: WHO good manufacturing practices for sterile pharmaceutical products (not online available)
Annex 5: WHO good distribution practices for pharmaceutical products
Annex 6: Guidelines on the requalification of prequalified dossiers
Annex 7: Guidelines for the preparation of a contract research organization master file
The annexes are part of the pdf file Technical Report No. 44.
Outcome:
If you are interessted in reading the hottest topics of the WHO report, check report's chapter 12 "Summary and recommendations" (Page 65 to 71) of the Technical Report No. 44.