The partnering of industry and regulators
Industries delivering goods and services beneath the life sciences umbrella are subject to regulations imposed at either the federal or state level. Within each industry, regulatory standards are used to define facilities, operations and record keeping.
by Hank Rahe
During the next few months this column will examine the changes in life sciences technology, within the areas of contamination control, to see how these changes have been impacted by regulatory agencies. We will look at trends and attitudes that also impact change. One trend: when industry and regulators work together, advances follow.
The scope of regulators ranges from the Food and Drug Ad-ministration (FDA), which provides guidance to pharmaceuticals, biologicals, medical device and the food industries, to state controlled agencies, such as pharmacy and medical boards. These agencies impact the delivery of health- care products and services. While individual industry segments often receive conflicting information from different regulatory agencies, they may even be caught between different divisions of the same agency.
The approval of products, facilities and operating methods, in many cases, is the difference between whether or not a company can continue to do business. The possibility of not doing business greatly reduces a company`s tolerance for innovation and risk taking. Because of this “no risk” mentality by companies delivering goods and services, the road to improved processes, increased quality and reduced cost is littered with discarded innovative ideas.
One technology that has survived the journey to industry acceptance within the pharmaceutical manufacturing industry is barrier/isolation technology. This technology offers advantages over the current industry practice for aseptic manufacturing of parenteral products. The advantages include both a reduction in the cost of manufacturing as well as improved quality of the final product.
Second place is the most coveted position when it comes to new technology within the pharmaceutical industry. In the case of barrier/isolation technology, an alternative approach of “safety in numbers” was chosen. The Barrier Users Group (BUG) offered an industry forum from which both pharmaceutical manufacturers and equipment suppliers could carry on open discussions with the FDA.
The technical details of engineering and fabricating barrier/isolators offered many challenges, including integration of process equipment and ergonomics. These obstacles seemed small compared to those raised in the technical discussions with the agency. Such issues as the classification of the area surrounding the barrier/isolators, internal environments of the barrier/isolators, and testing and validation methodology were addressed during the BUG forum.
Industry and agency individuals involved in the discussions believed that this technology, applied to the manufacture of parenteral products, would increase the quality of the product. This belief motivated the individuals to work toward developing the guidance and practice for implementation of the technology.
The collaboration of BUG and the FDA demonstrates the benefits that can be achieved by the partnering of industry and regulators. This approach minimizes the risk of being the leader of the cause, which, as stated previously, all pharmaceutical manufacturing companies tend to shun.
Hank Rahe is director of technology at Contain-Tech in Indianapolis. He is an expert in the areas of conventional and advanced aseptic processing. He is president of the International Society of Pharmaceutical Engineers, and is a member of the CleanRooms Editorial Advisory Board.