cGMPs / QRM Process

Sandoz' Ajaz Hussain Addresses IFPAC 2007

In this excerpt from his introductory remarks at IFPAC 2007, Dr. Hussain, former deputy director of FDA's CDER's Office of Pharmaceutical Sciences and a leader of the PAT movement, discussed the need to redefine specifications and quality to allow for continuous improvement.

Excerpted remarks by Ajaz Hussain, VP of Development at Sandoz, at IFPAC 2007. An audio file of this excerpt can be heard by clicking the Download Now button beneath the text transcription. Please note that this is not a complete transcription.



…Without the support and without the full confidence of Dr. Woodcock, none of these initiatives {PAT, 21st Century GMPs} would have ever happened. ..so thank you, Janet, for that.

…[When we started discussing these initiatives]….I did not have an appreciation of the efficiency challenges that the industry faces. I came from academia, not industry, and went on to FDA. I think that some of the efficiency numbers that defined the industry’s current low efficiency came from MIT.

The FDA discussions that occurred at the advisory committee… and Science Board meetings… were part of an eye-opening journey that led to the establishment of PAT and 21st Century GMPs…

We confronted many challenges. For instance, we considered the limits of the current system of validation…

…The whole aspect is, in some ways, looking outside pharmaceuticals. The journey from being a validated system to being a system that is in a state of control, as defined as statistical process control, is the message. In many ways, pharma lags behind other industries [in establishing these controls]…other industries have addressed this... and continuous improvement is taken for granted outside the pharma sector… but some of these concepts are almost foreign to pharma companies, in some way.

Much of this has been attributed to “regulatory uncertainty.” I think that regulatory uncertainty is real, and we confronted that at FDA, [and it must be addressed] as FDA continues to move this initiative forward.

…Pressure to reduce costs is increasing exponentially…

I now work for a generics company, and if I look at the Cost of Goods Sold and manufacturing, the cost of manufacturing [generics] is far, far higher than it is for innovator companies. For a generic company the cost of manufacturing is 50-60% of the cost incurred, it becomes more and more important to break into new efficiency practices.

From a healthcare perspective, considering competition and pressure to reduce healthcare costs, there is a significant requirement [to improve efficiencies]… if you really look at the costs that we could reduce by improving efficiency.

Having been a regulator and now, working in industry, I believe that what we started at FDA... really transformed [the industry] in the sense that you realized how inefficient the systems are, and what you really can do…

Moving forward, we have to continue progress but we face important challenges. Janet, Moheb and others at FDA are [doing this] … and one of the biggest challenges that Janet has talked about is the quality of therapeutics, which is probably the fundamental issue at the FDA and needs to be addressed in a more fundamental way.

[In other industries], defining quality is somewhat easier than it what it is for pharma. Defining customer satisfication for pharmaceuticals is not as simple.

Therefore, regulators must define quality [in the right way] so how we establish specifications is fundamental, but we still haven’t corrected the way we do it. The question is: How do you define specs in a modern sense for a large-scale manufacturer?

We still define specifications with a… compendial mentality. If we keep defining specifications this way, we will never improve.

We need a scientifically valid definition of what is out of specification… When you define specifications correctly, you can have continuous improvement. That cycle has not been completed yet.

You need a clear understanding of the state of control. Once you have defined control, you open the door to continuous improvement.

You may have a validated process but you then have to validate every change. Other industries don’t even have to think about this.

Currently, all changes are not continuous improvement, but each improvement is considered a change. If you have to have regulatory permission and approval [for improvement] the change won’t happen. It has to be seamless, and we’re not yet at that point.

As we move forward, knowledge-based decisions are the key. Mechanistic understanding is critical... We have to update definitions of quality.

One of the challenges at FDA… is that decisions are usually made based on empirical data/studies…How valid is that? We need to move to a more fundamental statistical approach.

Dr. Woodcock is our only hope of seeing that process move forward.

And it’s the way forward, not just for FDA, but for pharmaceutical companies, too.

After a year outside of FDA, I can say that I still believe fully that the initiatives that FDA has started are still the right way to move discussion forward.

You have the Critical Path and other initiatives that Dr. Woodcock is creating; these will all come together to solve quality issues…The key is to let science work for the benefit of the public and the industry.

You have to remember: If the industry does not make a profit, nobody will develop new drugs. It’s as simple as that.

Given legislative activities on the horizon, we have to ensure rigorous scientific foundation… and to move from decisions based only on empirical data to those based on mechanistic knowledge. That is the way forward.

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