The Medical Industry’s Move Toward Quality
The FDA will apply process management and risk-based initiatives to medical device and pharmaceutical reviews.

Stanley A. Marash, Ph.D.

One of the more widely publicized differences between ISO 9000:1994 and ISO 9001:2000 is the new standard’s effort to “promote the adoption of a process approach” to quality management systems. ISO 13485, which is specific to the medical device industry, goes even further, stating that it’s “based on a process approach to quality management systems.” In addition, the product realization requirements of ISO 13485 mandate that risk assessment planning and the resulting risk assessment data be used in formulating product requirements. Medical device manufacturers in the United States are now shifting from ISO 9001 compliance to ISO 13485 compliance, particularly if they’re doing business in Canada and Europe.

This process-oriented thinking has also affected the way the Food and Drug Administration looks at its pharmaceutical and medical device review processes. In the past, the FDA’s oversight of new-product quality involved two complementary approaches: reviewing technical information submitted by the manufacturer and inspecting manufacturing facilities for conformance to the Code of Federal Regulations’ requirements for current Good Manufacturing Practices for pharmaceuticals and medical devices. These approaches helped ensure the quality of medical products available in the United States.

However, as we approach the 25th anniversary of the last major revision to the pharmaceutical cGMP and the 10th anniversary of the most recent revision to the medical device cGMP, the FDA has announced that it will evaluate these programs’ currency.

Factors motivating the FDA to look at the cGMPs, particularly those related to pharmaceuticals, include:

The rapidly increasing number and variety of pharmaceutical products available

Increased use of medicines in health care

A desire to introduce new products more rapidly

Globalization of the pharmaceutical and medical device industries

Decreased frequency of FDA manufacturing inspections due to limited resources

Lessons learned from numerous approaches to regulating product quality

Advances in pharmaceutical sciences and manufacturing technologies

The application of biotechnology in drug discovery and manufacturing

Advances in quality science and management

To address these issues, the FDA announced an initiative called “Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach.” The initiative’s goals include:

Incorporating up-to-date concepts of risk management and quality systems approaches while continuing to ensure product quality

Encouraging scientific advances in pharmaceutical manufacturing and technology

Operating the submission review and inspection programs in a coordinated and synergistic manner

Applying regulations and manufacturing standards consistently

Encouraging innovation in pharmaceutical manufacturing

Using FDA resources effectively and efficiently to address the most significant health risks

To accomplish these objectives, the FDA plans to merge science-based risk management with an integrated quality systems approach. Some of the FDA’s pharmaceutical initiatives, as announced in recent public releases, include:

Risk-based orientation. To provide more effective public health protection, the FDA will weigh its level of effort against the magnitude of risk. Although the agency has been implementing risk-based programs, it will institute a more systematic and rigorous risk-based approach.

Science-based policies and standards. The last two decades have seen significant advances in pharmaceutical sciences and manufacturing processes. Although these advances have been incorporated into the FDA’s approach to product quality regulation, the changes require a thorough evaluation of the science base to ensure that product quality regulation incorporates up-to-date science while encouraging further advances in technology. Recent technology as well as standards such as ISO 14971, which provides guidance on applying risk management to medical devices, can also contribute significantly to risk assessment.

Integrated quality systems orientation. Principles from various innovative approaches to manufacturing quality will be evaluated for applicability and cGMP requirements, and related pre-approval requirements will be assessed according to pertinent principles. In addition, the pre-market review process and application of cGMP requirements will be viewed as an integrated process.

International cooperation. The globalization of pharmaceutical manufacturing mandates a global approach to regulation.

Strong public health protection. The initiative’s ultimate goals are to strengthen the public health protection achieved by the FDA’s regulation of pharmaceutical manufacturing processes and to maintain strong enforcement of existing regulatory requirements, even as the FDA examines and revises its approach to these programs.

During the current year, we’ll see many new initiatives concerning the review and approval of medical products, and I plan to discuss some of them in forthcoming columns. Among the subjects planned for subsequent articles are:

Process Analytical Technology

Applications of ISO 13485

Risk assessment and Hazard Analysis Critical Control Point systems

ISO 14971 and its relation to quality system regulation

The Prescription Drug User Fee Act of 1992

Progress toward 21st century pharmaceutical current Good Manufacturing Practices

Use of design for Six Sigma in reducing risk and improving quality

Fusion management’s role in integrating quality, regulatory and scientific processes

About the author

Stanley A. Marash, Ph.D., is chairman and CEO of The SAM Group, which includes STAT-A-MATRIX Inc. and Oriel Inc. Marash is the author of Fusion Management (QSU Publishing Co., 2003). Fusion Management is a trademark of STAT-A-MATRIX Inc. ©2004 STAT-A-MATRIX Inc. All rights reserved.