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