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
Example of QRM Implementation
This example of methodology is not intended to be issued by PIC/S as a recommendation or as a guideline for industry and/or for GMP inspectors but it could be used by PIC/S for training purposes.
Whether this example is used by industry for other purposes is of no concern to PIC/S and will not influence the outcome of PIC/S inspections.
Outcome
It will be usefull reading the document. Despite there are no obligations to do so, you can verify and improve your existing Quality Risk Management or you get some helpfull information when planing to implement your own QRM.
Link
Quality Risk Managemen implementation