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
Final Guidance: Standardized Numerical Identification
This guidance is intended to be the first of several guidances and regulations that FDA may issue to implement section 505D of the Act, and its issuance is intended to assist with the development of standards and systems for identification, validation, authentication, and tracking and tracing of prescription drugs. This guidance defines SNI for package-level identification only.
Outcome:
Check the Final Guidance for Industry! The document is there provided for online reading and in a printer friendly version.