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
Vet Quality: Public Consultation
The Concept Paper is now available at the Comitees Website. The Comitee comes to the following conclusion:
Conclusion
The development studies form a vital background on which to ensure that medicial products are of the quality appropriate to their indented use. A properly designed formulation manufactured in accordance with the principles of GMP using properly validated processes and test procedures should consitently comply with the desired finished product specification.
While the development sutdies are not normally within the control of GMP inspections, they should nevertheless comply with such principles where appropriate.
Properly conducted development studies should ensure that relevant release and shelf life specifications are applied in order that the desired characteristics of the product can consitently be met at release, and throughout shelf life.
Links:
EMA/ Concept Paper