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
Q4B, Annex 7 & 9 (FDA)
This annexes are part of a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry. For general information on the Q4B process, the reader is referred to the core guidance "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions".
Outcome:
FDA updates guidance documents periodically. To make sure you have the most recent version of a guidance, check the FDA Drugs guidance page or the FDA Biologics guidance page.
Links:
FDA/ Annex 7
FDA/ Annex 9
ICH/ Q4B