You do, that's who. FDA determines what "current" is based upon its experience with the manufacture of drugs, biologics, and medical devices through:
Note that of these five avenues, four involve contact with you in industry. Changes in your industry, whether they are highly technical and specific, or more of a shift in overall approach to a situation, do not go unnoticed by the Agency. The FDA's acceptance of such changes depends greatly upon how and why the changes came about. In general, there are two main reasons why "current" practices are changed.
The first results from advancement in technology. Whether your work is in manufacturing, research and development, quality control, or academia, you have the opportunity to develop and implement state-of-the-art processes. Once a new practice has been scrutinized by FDA and found to be compliant, it becomes the benchmark in industry for that process.
For example, the introduction of new analytical methods that perform significantly better than previously available methods can quickly cause old methods to become obsolete. The introduction of HPLC techniques allowed multiple actives to be easily separated and reliably quantified. Moreover, these new methods could be validated, and gained wide acceptance through use. HPLC is now the expected method of analysis for many pharmaceutical applications. The same is true of capillary electrophoresis as it stands now once the kinks are worked out (likely through greater automation), this promising technology will fast become the "current" method of choice for many analysts.
Now, you may be thinking, "That's nice. But implementing a new practice means making a change, and it's far too difficult to implement change under GMP." This is not necessarily true. The Agency may allow scientists and engineers flexibility in their process changes, provided that all steps are justified through sound scientific study and are performed under documented and controlled conditions by qualified personnel. This is where companies enter regulatory danger zones and consistently drop the ball. In addition to not properly reporting changes in applicable product applications, other fumbles include failing to plan and define in a protocol the studies employed when implementing change, and neglecting to establish the qualifications of the personnel involved in these studies. However, if your team can overcome these challenges to FDA's satisfaction, "change" does not have to be a drastic and dreaded word!
The second source of change is experience. For example, once upon a time, a long-standing relationship with a vendor accompanied by a Certificate of Analysis and little or no inspection/testing of incoming components often satisfied the GMP requirements for incoming components. As experience with GMP accumulated, both industry and FDA recognized that tighter control of vendor quality was necessary to ensure the quality of finished products. Now, a full vendor qualification (including audits, signed agreements, etc.) is expected before a firm may reduce full testing of incoming components to Certificates of Analysis and ID tests for chemicals, or reduced inspections for other components.
So, how do you manage to keep up with all that is current to your particular function? For instance, is the pertinent staff at your firm aware of the recent changes to 21 CFR Part 211 and the extensive changes pending to 21 CFR Part 820? FDA requires firms to communicate with and continuously train personnel on current GMP. The following is a partial list of suggested reading materials and activities that can help an individual or company in their quest to remain current:
Congress specifically chose the ambiguous word "current" to enable FDA to enforce appropriate contemporary practices for assuring the quality of drug and device products without constantly rewriting and reissuing the GMP regulations. Those affected by GMP are obligated to stay abreast of the latest developments in the manufacture and testing of their products. By becoming the originator of "current" good practices, you can gain the competitive edge on compliance in your field.
By Loui J. Silvestri, Ph.D., President, AccuReg
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