State of Quality and Compliance in the Biopharmaceutical Industry - Have FDA initiatives improved manufacturing quality? - BioPharm International


State of Quality and Compliance in the Biopharmaceutical Industry
Have FDA initiatives improved manufacturing quality?

BioPharm International
Volume 26, Issue 4, pp. 16-19


Change is always difficult, and the transformation of quality requires time and resources. However, we see the following potential solutions.

Embrace simplicity

Common sense and simplicity sometimes appear to be lacking. More complexity does not make better science. Paperwork and bureaucracy have increased to a point where they impede proper functioning of the quality and production systems. Management must look for new ways to provide the proper support, tools, and resources to help their personnel accomplish their jobs, and strive to be more effective facilitators of needed change.

Foster individual commitment and collaboration

No one functional unit can assure high quality and compliance, not even the quality assurance department. Instead, it must be a collaborative effort across all functional areas starting with each individual employee. This is particularly true in manufacturing, where they are the experts in the technologies and processes they use—and the first line of defense to assure the uninterrupted supply of high-quality products to the market. Manufacturing can't be successful on its own. The quality unit is needed to help assure the proper systems are in place, monitor those systems, and provide guidance when needed. To do this effectively, quality needs to have a presence on the shop floor. This helps the quality unit better understand the processes and technologies being used as well as the issues and challenges that can occur.

Getting everything done now

When people rush, mistakes happen, particularly when planning and preparation are inadequate for the task at hand. It is more difficult to correct problems after they happen than to prevent them from happening. It is better to devote the necessary time and resources in the planning phase. There needs to be a shift in thinking, attitudes, and behaviors so we don't place our companies, employees, and patients at risk when getting things done "now" is valued more than doing what is best for the situation at hand.

Use technology efficiently

Technology should introduce simplicity and efficiency, not complexity and inefficiency. Great technologies can become great impediments quickly. Unfortunately, there is no single technology that will solve all problems. Each technology must be evaluated for its benefits as a tool to improve manufacturing and product quality.

Employ effective risk management

The pharmaceutical industry must learn to assess and manage risk better. Risk management is a fundamental tool to help identify and remediate the challenges that may arise in support of attaining high and consistent quality. However, it has only recently been incorporated into the pharmaceutical quality system and has not reached its full integration and potential yet. Improvements must be made in the way risk assessment and analyses are performed and documented.


The recent surge in the number of enforcement actions suggests that the current state of quality and compliance in the pharmaceutical industry is far from optimal. While some advances have been made, it appears little progress has been made in others. Advances in technology and quality initiatives have not on their own resulted in improved product quality or better-controlled manufacturing processes. The causes are varied and frequently interrelated. Let's take another look inward, as well as outward, to see how best to accomplish the goals we all aspire to with regard to quality.

Anastasia Lolas is president of Visionary Pharma Consulting, LLC,
and Ian L. Uydess, PhD, is managing consultant at Tunnell Consulting, Inc.,

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