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:
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"Product quality and performance would be achieved and assured by design of effective and efficient manufacturing processes;
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Where product specifications would be based on mechanistic understanding of how formulation and process factors impact product performance;
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Where there would be continuous "real time" assurance of quality, and continuous quality improvement;
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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.
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