Take the risk
01/01/2001
by Hank Rahe
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Flexibility is a word that is not often spoken in an industry that requires a tortuous path of documentation for facilities, process and documentation changes. Many in the industry see the risk of changing facilities, process or equipment for the sake of improvement or cost reduction as not acceptable.
The reward for improvements in terms of cost savings is simply not worth the cost of review and the potential risk of loss of product approval. As cost pressures increase the industry must have the flexibility to make these changes not only in the United States but also globally without the current perceived risk.
Making changes to approved facilities, equipment or process requires a level of trust by the manufacturer that the changes will be acceptable.
To assure that the changes are acceptable only the extremely "safe" solutions are implemented, resulting in increased cost and time.
Another approach is to develop detailed industry-wide information for review by the agency and agree that if the information is followed the changes will be acceptable. Without a third party it has been very difficult to develop this industry-wide acceptable information. The industry issues most affected by the lack of flexibility are cost-effective facility designs, equipment changes to improve either efficiency or safety and the level of facility and process validation required. Each of these issues is now being addressed thanks to the involvement of societies such as International Society of Pharmaceutical Engineers (ISPE).
ISPE is taking the lead in working with industry and regulators to develop common ground. Facilities and validation issues have been addressed in the "Baseline Guide" series. Working with top technical talent from the pharmaceutical companies as well as the supporting service companies, ISPE is developing documents that contain information that describes an acceptable approach to the given subjects of facilities and validation. The FDA review of these documents gives the users of the documents an assurance that the contents are consistent with the agency's guidance.
The value of the Baseline Guide documents is their level of detail, which is greater than that provided in the agency's guidance documents. The detail makes the documents more usable by the technical professionals who are responsible for building the facilities or providing the documentation. This approach represents a win/win with the industry getting an understanding of what is required in both the facility and documentation and the agency being able to deliver a consistent expectation to the industry.
The net result is cost saving to both.
Another example of a third party bringing together the two sides is the U.S. Food and Drug Administration Scale-Up and Postapproval Changes (SUPAC) initiative, which is focused toward the identification of processing equipment that is similar in operation. The term "similar" means that materials processed by the individual pieces of equipment will result in the drug having the same characteristics. This has great values for the manufacturering companies as well as the agency. Companies under SUPAC have the flexibility to replace equipment with similar but not identical machines allowing improvements in safety without the burdensome need of changes to the drug product documentation. The agency also benefits by providing industry with more detailed guidance reducing the number of individual requests for changes as well as paperwork.
The key to working together is to have a trusted third party that can pull together the needed resources and produce a result that benefits both parties. ISPE is to be congratulated for having the foresight to see the need, mobilize the resources and deliver useful information that benefits both the industry and the FDA.
Hank Rahe is director of technology at Contain-Tech in Indianapolis. He has over 30 years' experience in the healthcare industry, as well as four years in academia. He is an expert in the areas of conventional and advanced aseptic processing. He is the past chairman of the board of the International Society of Pharmaceutical Engineers, and is a member of the CleanRooms Editorial Advisory Board.