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CDER 2007 Update
Drug Quality System
Our overhaul of the regulatory and quality control systems for pharmaceutical products encourages manufacturers to modernize their methods, equipment and facilities. Our goal is to help eliminate both production inefficiencies and undue risks for consumers. Our initiative implements improved policies that are making better use of our limited resources through more targeted and effective inspections.
We are improving both our external polices, known as “current good manufacturing practices” or cGMPs as well as our internal programs for the review of an application’s chemistry, manufacturing and controls sections. Pharmaceutical cGMPs for the 21st Century is the umbrella name for this strategic initiative, and more information is available at http://www.fda.gov/cder/gmp/.
Our vision for “desired state” in manufacturing
The desired goals of regulating manufacturing for both the industry and FDA for all products are:
- Product quality and performance assured by effective and efficient manufacturing processes.
- Product attributes based on mechanistic understanding of how formulation and process impact performance.
- Continuous improvement and continuous real-time assurance of quality enabled.
- Regulatory policies recognize the level of product and process knowledge.
New drug quality assessment
Our chemists have transformed drug quality assessment from a checklist review to a scientifically sound, risk-based process. Their mission is to:
- Assess the critical quality attributes and manufacturing processes of new drugs.
- Establish quality standards to assure safety and efficacy.
- Facilitate new drug development.
Biotechnology product quality assessment
We are also in the process of implementing the concepts of quality by design for biological products. The new process will closely follow the tenets already established for new drugs. We are in the process of designing a similar pilot program that will help us in developing a process for future submission and review of quality-by-design information in biologic license applications.
Generic drug quality assessment
We have developed a question-based review for quality evaluation of generic drug applications that is focused on product and process design and understanding. In January 2007, we fully implemented the initiative.
- We piloted and discussed the questions to determine how best to ensure that the quality-by-design applications would be beneficial both to the sponsors and to us in addressing quality-by-design concerns.
- We posted on the internet two models of the quality overall summary portion of an application and a frequently asked questions document to help generic drug sponsors implement quality by design and prepare high quality applications.
- We offered industry three workshops on how to prepare an effective quality overall summary and a generic drug basics course. We and the generic drug industry have held numerous teleconferences and Webcast meetings to discuss the progress of question-based review and to explain our expectations.
Focus on key product attributes for safety, efficacy
Our chemists are now focusing on critical pharmaceutical quality attributes and their relevance to safety and efficacy. These include chemistry, pharmaceutical formulation, stability, manufacturing processes, bioavailability and product performance. Our long-term goals are to:
- Emphasize quality by design in the evaluation of critical aspects of pharmaceutical quality.
- Have a strong focus on manufacturing science.
- Integrate review and inspection functions.
- Use modern statistical methodologies.
Quality-by-design pilot program
We have a formal pilot program under which pharmaceutical companies can voluntarily submit new drug applications that apply quality-by-design principles and demonstrate their product knowledge and process understanding.
This scientific information—more relevant than found in a traditional submission—will enable us to:
- Perform a risk-based assessment of product quality and process performance.
- Consider an applicant’s proposal for regulatory flexibility in setting product specifications and post-approval changes.
- Better understand information that is available for better assessing quality of products.
Workshop explores drug quality system
We have held several scientific workshops for industry to explore how we can achieve the new drug quality system. We worked with industry scientists to:
- Identify scientific training gaps that must be filled for the successful implementation of the new system.
- Obtain industry input on building a scientific, risk-based regulatory system that maintains high quality and facilitates continuous improvement.
- Help determine how to best use information from the pharmaceutical development phase in the industrialization phase.
- Identify the roles and responsibilities for industry and us in the new system.
- Propose ways to reduce the number of post-marketing supplements.
Process analytical technology
The Pharmaceutical cGMPs for the 21st Century Initiative stresses the need to apply more scientific and engineering knowledge to regulatory decision making and to the evaluation of manufacturing processes. The goal is to improve upon the overall efficiency and effectiveness of manufacturing processes and to enhance product quality. We have looked closely at manufacturing science to develop recommendations for improvements.
One of the areas that we are focusing on is the Process Analytical Technologies Initiative. The capability to use process analytical technologies encourages manufacturers to be innovative and to apply state-of-the-art quality assurance methodologies to their manufacturing processes. Process analytical technologies incorporate assessment of a product’s characteristics in real-time and feed that information back into process control systems that maintain the desired state of product quality throughout manufacturing.
We received a number of applications and manufacturing supplements in 2007 that incorporated process analytical technology into their manufacturing processes. More information on process analytical technologies can be found at http://www.fda.gov/cder/OPS/PAT.htm.
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Date created: July 31, 2008 |
