FDA Wants You in Control

FDA has thrown a lot your way lately. Bar code rules, RFID use for anticounterfeiting, and new electronic labeling requirements are just a few of the recent edicts to come out of the agency. As inundated as you must feel, don�t worry�FDA is not trying to micro-manage you. In fact, the agency may begin managing you a bit less.

Sound too good to be true? It is all part of FDA�s risk-based approach to regulation. During the opening address at Interphex 2004 in March, FDA deputy commissioner Janet Woodcock reported progress toward the agency�s initiative, �Pharmaceutical CGMPs for the 21st Century�A Risk-Based Approach.� Part of that risk-based approach is the use of emerging science to maintain product quality. 

FDA knows that you know science better than it does. �We want to make sure that up-to-date science is incorporated in regulations,� Woodcock explained. �Manufacturers are much more advanced in quality systems than we are. We are looking at how GMPs stack up against modern quality systems.� (For more on Woodcock�s speech, see the news story on page 12.)

FDA�s latest feat in its initiative is its policy guide, �Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval,� released in March. It replaces �Process Validation Requirements for Drug Products Subject to Pre-Market Approval.� This new policy will guide agency staff during compliance decisions. 

The agency�s Web site says that the new guide recognizes �the role of emerging advanced engineering principles and control technologies in ensuring batch quality. For drugs produced using these new principles and technologies, this [guide] provides for possible exceptions to the need for manufacturing multiple conformance batches prior to initial marketing.� In other words, manufacturers submitting NDAs do not necessarily need to submit three batches produced 
at commercial scale as proof of process validity�a specific number of batches is no longer suggested.

During her speech, Woodcock said that since FDA and industry really have the same customer�the patient�the two can work together to achieve the same goals. �FDA regulates product quality. If processes are in control, then quality is under control,� she said.

FDA, therefore, will be watching to see how much control you have over your processes. And packaging is one of those processes. �We see nothing worse and more inefficient than batch inconsistencies,� she said. And all firms will be expected to demonstrate that they can maintain control. �For no product category will we give up inspections. It just means for some products, some inspections will be more intense.�

Perhaps the good news is that FDA won�t be so quick to tell you how to control your quality. �We now have a dispute resolution process whereby companies can appeal technical decisions,� said Woodcock. �We encourage people to use it. If our approach doesn�t contribute to the quality of your product, you should stand your ground. Science is about the open exchange of ideas.�

In other words, don�t hold back. Show FDA that you are in control.

Daphne Allen


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