28/29 January 2020
GMP News No. 801
26 September 2006
FDA Publishes Guidance Agenda for the Coming Fiscal Year 2007
This year's list includes a number of interesting initiatives:
In the field of biologics (CBER):
In the field of veterinary drug products (CVM):
In the field of drug products/chemistry (CDER):
What will certainly also be interesting is the Guidance "Importation of Active Pharmaceutical Ingredients". Another remarkable fact is that the FDA plans to issue a guidance on Quality by Design. Since documents that are being harmonised through the ICH process are marked in the list, it seems as though the FDA wanted to publish a guidance in addition to the document ICH Q8.
The pharmaceutical industry has been waiting a long time for the review of the guidance on process validation: general principles and practices. Now that the corresponding Compliance Policy Guide (CPG) has been adapted, this document is overdue. According to the information in hand, the guide will continue the new risk-based implementation (among other things waiving the 3 magic validation runs) in a consistent way.
On the whole, one can say that the FDA stays on the course of the cGMP
for the 21st Century Initiative (http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm).
GMP Events with FDA Speakers!
At the following events in Europe, you have the opportunity to discuss the implementation of the different requirements directly with official FDA representatives:
Conference organised by APIC/CEFIC:
Conference organised by ECA:
The following ECA events also deal with FDA compliance:
Source: Guidance Agenda http://www.fda.gov/OHRMS/DOCKETS/98fr/oc0689.pdf