FDA Details Its Visions of the "cGMP for the 21st Century Initiative"

GMP News No. 708

GMP News
19 April 2006

FDA Details Its Visions of the "cGMP for the 21st Century Initiative"

On the occasion of the 30th International GMP Conference, which took place at the University of Georgia in the middle of March, Scott Gottlieb, FDA Deputy Commissioner for Medical and Scientific Affairs, gave details of the Agency's GMP Initiative.

According to Gottlieb, the FDA intends to develop new regulation policies on the basis of the latest scientific research on risk management and quality assurance. The new standards are meant to contribute to the reduction of costs in manufacture and technology and to the promotion of innovations that lead to higher precision. Equally, the Agency wants to make sure that the same up-to-date methods are employed by all three FDA Centers - including inspectors concentrating on specific production methods.

Furthermore, the FDA wants to benefit from the current knowledge gained in manufacturing practice when making regulatory decisions and to establish generally accepted quality specifications in order to be able to assess the manufacturing process better. Through an integrated systems approach both sides work on jointly to regulate product quality, the Agency aims at significantly improving both manufacturing processes and regulatory processes. On the whole, Gottlieb characterises the programme as a model where:

  • "Product quality and performance would be achieved and assured by design of effective and efficient manufacturing processes; 

  • Where product specifications would be based on mechanistic understanding of how formulation and process factors impact product performance; 

  • Where there would be continuous "real time" assurance of quality, and continuous quality improvement; 

  • Where regulatory policies and procedures would be tailored to recognize the level of scientific knowledge supporting product applications, process validation, and process capability, and; 

  • Where risk based regulatory scrutiny would relate to the level of scientific understanding of how formulation and manufacturing process factors affect product quality and performance and the capability of various strategies to prevent or mitigate the risk of producing poor quality products."

With this initiative, the FDA intends to develop further and modernise the regulation of the manufacturing process and the product quality and therefore to adapt them to the needs and possibilities of the 21st century. The aim is to motivate manufacturers to modernise their methods, equipment and facilities, to reduce the costs, improve the quality and eliminate the deficiencies that sometimes even prevent medicinal products from being released.

For the FDA, the most important element is the introduction of modern quality control systems that have led to improved production processes in other industries - since quality cannot be "tested into" products, but must be "built into products by design".

From the Agency's point of view, this includes the implementation of PAT (Process Analytical Technology) during the entire process in order to ultimately ensure product quality and to define suitable measures already during the manufacturing process.

However, the FDA is conscious of the fact that it has to understand the complete manufacturing process to reach this target. Therefore, the "Office of New Drug Quality Assessment" (ONDQA) headed by Moheb Nasr is developing a new quality assessment system based on scientific knowledge on product and process and applying the principles of "Quality by Design" (QbD). The objective of this development is the promotion of product and process innovations and continuous product improvement throughout the complete life cycle.

In order to develop an internationally harmonised Quality-by-Design approach, the FDA co-sponsored a workshop last autumn. Besides, the authority is working on an ICH Guideline with a comprehensive summary on quality. In addition, the Agency intends to publish its approach of taking over QbD in a guidance and plans the publication of its final guidance on quality systems for summer 2006.

The new FDA Draft Guidance for Industry: "Quality System Approach to Pharmaceutical cGMP" is seen as one of the core elements of the FDA initiative for reforming the GMP/QA requirements. On this topic, we organise:

FDA's and ICH's New Quality Systems Approach in Prague on 1-2 June 2006

Wolfgang Heimes
On behalf of the European Compliance Academy (ECA)

Source: FDA Website – http://www.fda.gov/oc/speeches/2006/gmp0314.html

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