31 August - 3 September 2021
GMP News Nr. 232
4 September 2002
New Initiative by FDA
On August 21, 2002 the Deputy Commissioner of FDA, Dr. Lester M. Crawford,announced a significant new initiative on the part of FDA. This initiativeis entitled "Pharmaceutical cGMPs for the 21st Century: ARisk-Based Approach".
Its purpose is to improve the regulationof pharmaceutical manufacturing and product quality and to place the focusin the 21st century on this regulatory responsibility of FDA.
The initiative concerns bothmanufacturers of human medicinal products as well as manufacturers ofveterinary medicinal products.
Dr. Crawford sees the FDA regulatory andquality control systems as the worldwide "gold standard".Nevertheless, FDA is aware of the fact thateven a good system still has room for improvement. And this is what thisinitiative is aimed at.
Crawford names 3 main goals as thebasis of this new FDA initiative:
In order to achieve these 3 main goalsFDA would like to apply 5 principles as a guide:
In order to be able to implement theseprinciples FDA is planning on holding workshops in the near future withthe key stakeholders (industries, universities, government, consumergroups). It also intends to intensify training activities within FDA inorder to attain a better knowledge of new pharmaceutical technologies. Infuture specialists are to be able to joint the inspection teams whenneeded. Furthermore, the procedures within Team Biologics are to beimproved.
Much emphasis is placed on the risk-basedapproach for work concerning FDA. In addition a scientific and technical reviewof all Warning Letters is to be carried out by the FDA centers.
The announcement that theresponsibilities for the implementation of 21 CFR 11 will in future bewith CDER and no longer with the agency comes as a surprise. In aquestion and answer paper Dr. Crawford replied to the question as towhether a manufacturing process would not be inspected if the industrycould convince FDA that there were only little risks. "No. ... FDAalso recognizes that enforcement against indirect health risks isimportant too.".
And to the question of whether FDA wantsto continue improving the cGMP Rules Dr. Crawford answered clearly in theaffirmative and pointed out that the cGMP program is highly successful. Itis also the purpose of this initiative to enhance it further. Ifnecessary, GMP Guidances could also be updated accordingly.
Despite the fact that FDA is currentlyrevising its blood regulations ("Blood Action Plan") the newinitiative will not focus on blood GMP or on the planned Good TissuePractice (GTP) regulation.
Conclusion: At this early point intime it is difficult to forecast the effects of this initiative on theindustry. It is, however, clear now already that risk and qualitymanagement will occupy a distinctly greater priority at FDA than hashitherto been the case. It is also to be expected that the attention givento cGMP requirements will constitute a new challenge for the companiesconcerned. Although FDA makes no direct reference to the current WarningLetters and the Consent Decree, their influence can be felt in theprogram. And the fact that the recently uncovered severe GMP defects inproduction and quality assurance were discovered in particular in largecompanies may have caused FDA to pay more attention to GMP.
On November 15, 2002 in Barcelona FDADirector, Dr Chiu, will speak at 5thEuropean GMP Conference on Active Pharmaceutical Ingredients. Hertopic will be the current revision of the 1987 API Submission.