Medical Device Link.

Originally Published PMPN November 2002

OUR VIEW

Investing in a quality system can help packaging professionals resolve CGMP problems and avoid FDA penalties.

J. Michael McKay, president and CEO, SQA Services Inc.

Over the years, current good manufacturing practice (CGMP) violations in the pharmaceutical industry have increased at an alarming rate, and penalties imposed by FDA have failed to alleviate the problem.

One reason the situation has not improved is that a regulatory approach based on catching and addressing rule violations focuses on symptoms rather than on their causes. It also puts the onus on FDA to police companies and make sure they are in compliance. The problem, therefore, is twofold: FDA is obliged to monitor companies because they keep breaking the rules, and companies keep breaking the rules because they are preoccupied with addressing the symptoms and not the causes.

To help deal with the escalating CGMP problems, FDA must change its approach to regulation. It is starting to do so with the CGMP review, which is aimed at developing a more consistent approach to evaluating quality systems. But rather than wait for FDA, companies should develop systems that ensure quality by addressing the problems at their origins.

Companies need to shift their focus to quality systems to help them detect problems, resolve them, and prevent them from recurring. In addition to maintaining consistent processes, like those involved in filling and sealing packages, a quality system mandates self-evaluation and continuous improvement. It addresses problems at their roots. A quality system should spot problems before they occur.

An effectively implemented and supported quality system simply does not allow process failure of the magnitude seen in the high-profile FDA crackdowns. One key feature of a quality system is its formal method for corrective action. This ensures that problems with products, processes, or people are addressed quickly and that steps are taken to prevent those problems from recurring.

Quality systems also ensure that the right information is flowing through the organization. With a heavy emphasis on communication, feedback, review, and basic management, quality systems ensure that issues stay in the limelight until appropriate action is taken. This is an integral part of a company's early-warning systems—something that could have saved some pharmaceutical manufacturers from FDA's wrath.

With a quality systems approach, the regulatory process is turned upside down. FDA's original and underlying intent is still the same; however, now the onus is on companies to improve rather than be policed.

If the mechanisms and the mindset are not already in place, implementing a quality system will be a significant change for a company. Firstly, the cost of quality is tied up in fighting fires and paying penalties. Shifting this investment into prevention will not be easy—even though it is almost certain to pay off financially—and preserving the status quo will have its own appeal. Secondly, the current approach to regulation does not motivate companies to make this change.

The cultural change needed will require as much of an investment as will implementing the formal structures. Raising awareness and promoting understanding will require significant education and training. The organizational constitution will also need changing, providing quality representation at the highest levels. Lastly, companies must ensure that an objective body within or outside the organization is responsible for self-assessment.

By committing to a quality systems initiative, manufacturers develop the capability and capacity to improve. They can still address symptoms of problems they experience, but they will have the systems that can resolve them permanently. This alone will help them avoid high-profile penalties. Combined with a change in FDA's approach, quality systems will have a dramatic impact on the industry.

J. Michael McKay is president and CEO of SQA Services Inc. (Rolling Hills, CA), a professional services firm specializing in supplier quality management.

Copyright ©2002 Pharmaceutical & Medical Packaging News