Quality Systems for Drugs and Biologics - Pharmaceutical Technology

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Quality Systems for Drugs and Biologics
FDA is modernizing and streamlining current good manufacturing practices. The author examines FDA's evolving approach to quality systems and how a manufacturer can implement a quality system framework.


Pharmaceutical Technology



Figure 4: Hazard control.
The concepts of hazard control should be applied to the product and the process. These concepts are described in Table I.

It is important to look at these core principles through the lens of PAT. PAT is really another way to describe advanced process control and is better described as "process analytical control technology." There is a need to deal first with the process and then the analytical pieces before the technology can have any meaningful use. Both FDA and the industries are looking at new technologies as the silver bullet to cure all of our quality ills, but it will be more important to build the gun first and know where to point it to be able to fire it and hit the target.

For PAT to be successful, the effort should be applied first to the development of a deep scientific understanding of the process and designing that process and its controls appropriately based on the target of constant output. This requires an understanding and application of the concept of critical control points and a full understanding of how the process works and how the process and its output are affected by variations in materials and control conditions. Next, one must understand how and where the process can be measured. One should only measure and analyze the things that really matter, based on process knowledge. There's no rational point in measuring things simply because we can, so this also must be tied into the concept of critical control points and how the process and its output are affected by variations. Finally, a successful PAT strategy requires a true understanding of how and where the process can be measured and effectively adjusted and controlled during production to constantly ensure consistent output.

Fancy technology doesn't mean a thing without the necessary process and analytical knowledge. FDA is pushing for quality system approaches that have been used for a long time in other industries (i.e., the electronics, defense, oil and gas, and telecommunications industries).

Inefficiency in the pharmaceutical industry could be wasting more than $50 billion per year in manufacturing costs alone—costs that could translate into lower prices or greater research and development—according to findings of the largest empirical study ever performed of pharmaceutical manufacturing and FDA monitoring policies (11).

Quality and compliance are not the same

Quality done right will result in compliance. Compliance, on the other hand, will not necessarily create or ensure the quality of processes or products. An organization must have both to succeed. The quality of a product is based upon the quality of the processes used in its manufacture. If one has poorly developed processes and procedures, continued compliance with the existing quality system will just ensure that one has consistently have poor product quality and integrity.

Use business drivers to change your quality system

Two key drivers of management's behavior and direction are regulatory compliance and operating costs–profit margins. A management team must focus on both. The consequences of noncompliance (business threat) as increased ongoing costs should be emphasized because focusing on the regulatory threat usually is not the most effective way to change management's views and actions. Use the company's own business realities as a driver. Understand how quality is related to business objectives (profits and cost-of-goods) and how they can be used to drive quality system improvements.


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