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, donï¿½t worryï¿½FDA 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 FDAï¿½s risk-based approach to regulation. During the opening address at Interphex 2004 in March, FDA deputy commissioner Janet Woodcock reported progress toward the agencyï¿½s initiative, ï¿½Pharmaceutical CGMPs for the 21st Centuryï¿½A Risk-Based Approach.ï¿½ 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. ï¿½We want to make sure that up-to-date science is incorporated in regulations,ï¿½ Woodcock explained. ï¿½Manufacturers are much more advanced in quality systems than we are. We are looking at how GMPs stack up against modern quality systems.ï¿½ (For more on Woodcockï¿½s speech, see the news story on page 12.)
FDAï¿½s latest feat in its initiative is its policy guide, ï¿½Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval,ï¿½ released in March. It replaces ï¿½Process Validation Requirements for Drug Products Subject to Pre-Market Approval.ï¿½ This new policy will guide agency staff during compliance decisions.
The agencyï¿½s Web site says that the new guide recognizes ï¿½the 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.ï¿½ In other words, manufacturers submitting NDAs do not necessarily need to submit three batches produced
at commercial scale as proof of process validityï¿½a specific number of batches is no longer suggested.
During her speech, Woodcock said that since FDA and industry really have the same customerï¿½the patientï¿½the two can work together to achieve the same goals. ï¿½FDA regulates product quality. If processes are in control, then quality is under control,ï¿½ she said.
FDA, therefore, will be watching to see how much control you have over your processes. And packaging is one of those processes. ï¿½We see nothing worse and more inefficient than batch inconsistencies,ï¿½ she said. And all firms will be expected to demonstrate that they can maintain control. ï¿½For no product category will we give up inspections. It just means for some products, some inspections will be more intense.ï¿½
Perhaps the good news is that FDA wonï¿½t be so quick to tell you how to control your quality. ï¿½We now have a dispute resolution process whereby companies can appeal technical decisions,ï¿½ said Woodcock. ï¿½We encourage people to use it. If our approach doesnï¿½t contribute to the quality of your product, you should stand your ground. Science is about the open exchange of ideas.ï¿½
In other words, donï¿½t hold back. Show FDA that you are in control.