Pharmaceutical Frequently Asked Questions

The Food and Drug Administration (FDA) regulates foods, drugs, medical devices, biologics, animal feed and drugs, cosmetics, radiation-emitting products, and combination products.

The mission of the FDA is:

• “To promote and protect the public health by helping safe and effective products reach the market in a timely way,
• To monitor products for continued safety after they are in use, and
• To help the public get the accurate, science-based information needed to improve health.”
  

What divisions of FDA regulate drug products?

The Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Veterinary Medicine (CVM) all play central roles in assuring that safe and effective drugs are available to the American public.

Drugs are chemically synthesized, while biologics are derived from living sources such as humans, animals, and microorganisms. CVM regulates the manufacture and distribution of drugs that will be given to animals. There is also an Office of Combination Products that regulates products comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic products.

What is the FDA vision for pharmaceutical development and manufacturing in the 21st Century?

FDA’s initiative in pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st century is intended to enhance and modernize the regulation of pharmaceutical manufacturing and product quality.

This is to be accomplished by:

1. Encouraging the early adoption of new technological advances by the pharmaceutical industry
2. Facilitating implementation of quality systems approaches to all aspects of pharmaceutical production and quality assurance
3. Encouraging implementation of risk-based approaches that focus attention on critical areas
4. Ensuring that regulatory review, compliance, and inspection policies are based on state-of-the-art pharmaceutical science
5. Enhancing the consistency and coordination of FDA's drug quality regulatory programs, in part, by further integrating enhanced quality systems approaches into the Agency’s business processes and regulatory policies concerning review and inspection activities.

What is FDA’s risk-based approach to CGMP?

The risk-based approach to CGMP aims at effective allocation of FDA resources applied to regulatory review, compliance, and inspection.

For example, the frequency and/or scope of inspections will be reduced for firms that FDA determines have acquired sufficient process understanding and have succeeded in implementing effective quality systems. In addition, FDA expects that applying a risk-based approach to the product quality review process will facilitate continuous improvement in pharmaceutical manufacturing.

What is PAT?

The FDA’s Process Analytical Technology (PAT) initiative is an effort to facilitate the introduction of new manufacturing technologies in the pharmaceutical industry in order to implement more innovative pharmaceutical development, manufacturing, and quality assurance processes.

Process Analytical Technologies are systems that enhance process understanding, reduce variability, and assist in identifying and controlling critical points in a process.

These include:

• Appropriate measurement devices that can be placed in-line
• Statistical and information technology tools
• A quality systems approach for data analysis to control processes and ensure production of in-process materials and final products of desired, consistent quality

Can STAT-A-MATRIX help with interpreting all of these changes and developing programs to address them?

STAT-A-MATRIX can help pharmaceutical and biotech organizations understand, develop, and implement quality process management systems compliant with FDA regulations and international harmonization guidance.

We are uniquely qualified to help with these regulatory initiatives because we have worked with numerous FDA-regulated organizations to develop a broad range of quality systems that stress quality management, quality assurance, design control, and the use of risk management tools, in addition to the fundamental quality control requirements in FDA CGMPs.

For example, the STAT-A-MATRIX 14-step implementation process develops a modern quality system with the necessary framework for building in quality from the drug product development phase, during the application of process analytical technologies in manufacturing, and throughout the drug product lifecycle.

The STAT-A-MATRIX 14-step implementation process can also be used to strengthen or initiate Lean Six Sigma programs. This is significant because FDA has stated it is important that the CGMP regulations are harmonized to the extent possible with other widely used quality management systems, including ISO 9000. Since ISO has adopted a process approach model that pursues continual improvement and customer satisfaction, the business benefits of implementing Lean Six Sigma processes are now even more clearly aligned with the regulatory imperative of prevention of defects.

Does STAT-A-MATRIX work with start-up companies as well as established organizations in the pharmaceutical industry?

STAT-A-MATRIX has programs and consulting capabilities to help guide newcomers through the often overwhelming maze of regulatory compliance and international standards certification requirements. Our highly experienced consultants—most of whom have been through this process in the corporate world and many of whom are former FDA investigators—understand your needs as well as your concerns.

STAT-A-MATRIX also works with major pharmaceutical companies to sharpen or refresh employee skills and capabilities, providing experts in specific subject areas as needed, as well as to educate and inform their new employees. Likewise, STAT-A-MATRIX works with start-up companies to jump-start their programs and cost-effectively address new initiatives.

Is compliance with the FDA regulations the same as conforming to ICH guidelines or ISO standards?

Compliance with FDA regulations goes a long way toward preparing your organization to meet ICH guidelines and ISO standards, but they are not interchangeable. Without adequate CGMP compliance, for example, drug products are considered adulterated.

FDA CGMP guidance documents, on the other hand, are not requirements. They represent current thinking on acceptable practices. Likewise, ICH guidelines and ISO standards are not requirements, but guidelines developed by expert working groups made up of industry and governmental representatives from member countries around the world.

While there is an overall trend toward harmonizing standards and regulations governing pharmaceutical products, voluntary guidelines have a customer focus that is outside the regulatory mandate to protect the public health.

What are some other areas where STAT-A-MATRIX can help?

Awareness is growing in the pharmaceutical industry that it’s not enough to know how to comply with regulations and conform to standards. Organizations need to understand how to integrate regulations and standards into valuable business-building outcomes.

To that end, STAT-A-MATRIX combines extensive experience in FDA compliance pathways with the process management practices that enable a company to make effective use of the pathways to support their business objectives.

For instance, we emphasize process models that link the compliance/conformance needs with process development and business activity-interface management and control. Another aspect of our approach is to tie together the various elements of a robust quality management system with the methods to monitor, control, and sustain those elements. Still another aspect of our approach is linking problem solving and project management with compliance activities.

What training programs does STAT-A-MATRIX offer that may be appropriate to my needs?

STAT-A-MATRIX offerings are comprehensive and robust:

• Understanding FDA’s Current Good Manufacturing Practice (CGMP) for Finished Pharmaceuticals and Quality Systems Guideline
• Applying Lean Six Sigma for meeting FDA’s Process Analytical Technologies (PAT) Initiatives
• Design Control Concepts and Implementation as a Platform for Quality by Design
• Risk Management and Analysis for Pharmaceuticals

And, of course, customized consulting and training services are available to meet your specific needs. For more information on these or other services, email customerservice@statamatrix.com, or call 800-472-6477.