New Initiative by FDA

GMP News Nr. 232

GMP News
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 initiative is entitled "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach". 

Its purpose is to improve the regulation of pharmaceutical manufacturing and product quality and to place the focus in the 21st century on this regulatory responsibility of FDA. 

The initiative concerns both manufacturers of human medicinal products as well as manufacturers of veterinary medicinal products. 

Dr. Crawford sees the FDA regulatory and quality control systems as the worldwide "gold standard". Nevertheless, FDA is aware of the fact that even a good system still has room for improvement. And this is what this initiative is aimed at. 

Crawford names 3 main goals as the basis of this new FDA initiative: 

  • To focus the attention, resources and cGMP requirements of FDA more on potential risks to public health. 
  • To ensure that the development and implementation of new product quality standards of FDA do not hinder any innovations or new manufacturing techniques. 
  • To improve the consistency and predictability of FDA (better coordination between FDA's centers and field offices). 

In order to achieve these 3 main goals FDA would like to apply 5 principles as a guide: 

  • Risk-based orientation, since scarcity of resources prevents a uniformly intensive treatment of all pharmaceutical products 
  • Science-based policies and standards, since obsolete technology can also be a risk factor in pharmaceutical manufacture. 
  • Orientation as regards integrated quality systems in order to improve coordination between pre-approval and compliance inspections
  • International cooperation in the form of a collaboration with other regulatory authorities 
  • Strong public health protection, which is to be improved 

In order to be able to implement these principles FDA is planning on holding workshops in the near future with the key stakeholders (industries, universities, government, consumer groups). It also intends to intensify training activities within FDA in order to attain a better knowledge of new pharmaceutical technologies. In future specialists are to be able to joint the inspection teams when needed. Furthermore, the procedures within Team Biologics are to be improved

Much emphasis is placed on the risk-based approach for work concerning FDA. In addition a scientific and technical review of all Warning Letters is to be carried out by the FDA centers. 

The announcement that the responsibilities for the implementation of 21 CFR 11 will in future be with CDER and no longer with the agency comes as a surprise. In a question and answer paper Dr. Crawford replied to the question as to whether a manufacturing process would not be inspected if the industry could convince FDA that there were only little risks. "No. ... FDA also recognizes that enforcement against indirect health risks is important too.". 

And to the question of whether FDA wants to continue improving the cGMP Rules Dr. Crawford answered clearly in the affirmative and pointed out that the cGMP program is highly successful. It is also the purpose of this initiative to enhance it further. If necessary, GMP Guidances could also be updated accordingly. 

Despite the fact that FDA is currently revising its blood regulations ("Blood Action Plan") the new initiative will not focus on blood GMP or on the planned Good Tissue Practice (GTP) regulation. 

Conclusion: At this early point in time it is difficult to forecast the effects of this initiative on the industry. It is, however, clear now already that risk and quality management will occupy a distinctly greater priority at FDA than has hitherto been the case. It is also to be expected that the attention given to cGMP requirements will constitute a new challenge for the companies concerned. Although FDA makes no direct reference to the current Warning Letters and the Consent Decree, their influence can be felt in the program. And the fact that the recently uncovered severe GMP defects in production and quality assurance were discovered in particular in large companies may have caused FDA to pay more attention to GMP. 

On November 15, 2002 in Barcelona FDA Director, Dr Chiu, will speak at 5th European GMP Conference on Active Pharmaceutical Ingredients. Her topic will be the current revision of the 1987 API Submission. 



FDA Compliance is the subject of all ECA events listed below


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