Monday, 20 September 2021 14.00 - 15.30 h
Will the FDA Continue Its Initiative "cGMPs for the 21st Century"?
The 2007 report describes the changes since the first report on the FDA initiative "cGMPs for the 21st Century" published in 2004. Besides, it is meant to show that the topic is still up to date and therefore being pursued. In principle, the FDA initiative concentrates on 5 points:
The 8-page overview then addresses activities in connection
with the FDA initiative. First it deals with the topic of communication. Here
the text lists workshops held between 2005 and 2007, but also draft guidances.
The paragraph on Quality Management Systems describes internal and external
activities. It explains different systems that have been developed or
implemented (e. g. CMC Review). A separate paragraph is dedicated to
international co-operations, among others the participation in the ICH and
potential PIC/S membership. Another section describes the FDA's PAT activities.
Interestingly, the text expressly points out a PAT Committee founded recently by
the ASTM. What is also mentioned is the establishment of a Pharmaceutical
Inspectorate within ORA as well as the scientific collaboration with
universities and the introduction of "standards" for the acceleration of
procedures. A detailed statement is given on Quality by Design.
This leads us back to the starting point of the question: "What
is to be expected in the future?" One could express it in the catchy phrase:
"Everything is Quality by Design." The FDA considers "Quality by Design" to be
playing a pivotal role in drug manufacture. It results in the corresponding
designs for the process and the product accompanied by a suitable control
strategy with the objective to maintain process understanding and product
knowledge. And all of this is intended to be continually improved. Here, we can
see a direct reference to the methods coming from the field of six sigma. One
possible method for controlling and understanding a process could e. g. be
statistical process control (SPC).