Discussion

Attaining and maintaining high standards should be the goal of all organizations that involve animals in research, testing, and teaching. The three systems described can all be applied to help achieve this goal, either individually or in combination. Many pharmaceutical companies, contract research organizations (especially those conducting toxicology testing), and centralized laboratory institutes18,19 integrate all three into their animal care and use programs.

The fact that three distinct assessment systems can be employed simultaneously is not surprising when one examines their origins, procedures, and ultimate aims. Although aspects of the systems differ to greater and lesser degrees, they should be viewed as complimentary rather than exclusionary.20,21

Beginning with an examination of their histories, it is clear that the GLP system came into existence in response to serious adverse events — illness, deformities, and even death — related to the development and sale of products consumed by humans. Thus, GLPs are heavily oriented toward avoiding harm to humans. Given the complex nature of drug development, it is logical that this assessment system involves strict adherence to rather inflexible requirements at multiple points in that process. The principal focus of GLPs is on high-quality data.

Review of the origin of ISO reveals that organizational founders were primarily concerned with the need for the international harmonization of standards. Standard development continues to be its main orientation, and the list of ISO standards is both extensive and diverse. Although the vast majority of ISO standards are in areas unrelated to animals, the 9000-2000 series dealing with quality management can clearly be applied to the operation of animal care and use programs, especially for multinational corporations wishing to demonstrate consistency among their operational locations. The principal focus of ISO 9000-2000 is on developing a high-quality product and ensuring consumer satisfaction with that product.

From its inception, AAALAC International has been primarily concerned with how animals are cared for when they are involved in research, testing, and teaching. AAALAC International was founded on the belief that sound science requires that animals used in its pursuit should be maintained in a uniform manner under high standards. It is not surprising then that the AAALAC International accreditation process continues to emphasize animal care and use, with the goal of minimizing the "animal variable" in science. Animals themselves, and the uses to which they are put, vary in a myriad of ways. This requires that AAALAC International standards and procedures be sufficiently flexible to accommodate these diversities. The principal focus of AAALAC International is on animal welfare.

The differing focuses of GLPs, ISO, and AAALAC International quite naturally lead to variations in how the three systems accomplish their goals. Minimizing (hopefully to zero) the possibility that a new drug or device will cause unintended harm to human patients leaves the FDA with few options other than requiring absolute adherence to means-related standards. Almost no deviation from highly prescriptive "engineering" standards is allowed, with verification of adherence to GLP requirements accomplished by both strict internal controls and unannounced inspections by representatives of national authorities. These national authorities have ultimate approval power and are the final arbitors of whether or not an organization has complied with the requirements.

With its focus principally on products and consumer satisfaction, ISO is primarily concerned with processes and procedures. Customer feedback is critical to enhancement, on an ongoing basis, of the processes that will lead to a consistent, high-quality product. When ISO management systems are applied to animal care and use, the products are both "hard," i.e., healthy animals, and the service provided to maximize accurate, reproducible scientific results. As the body that both develops standards and evaluates their implementation, ISO utilizes professional external evaluators to assess conformance to its standards.

Accomplishing the goal of promoting animal welfare internationally requires a level of flexibility generally greater than that associated with ISO and largely forbidden under GLPs. Accommodating different species and circumstances of their use is manifested in both the standards employed by AAALAC International and the procedures followed to assess organizations' adherence to them. The Guide and Reference Resources that form the "AAALAC International Standards" are almost exclusively performance- or outcome-based, providing (sometimes wide) latitude in the ways that organizations may choose to meet the performance standards.22,23 Under these circumstances, the only practical method for determining whether or not an organization has met the desired outcome is through the process of peer review by individuals with proven abilities to apply professional judgment in a consistent manner.24

0 0

Post a comment