On August 24, 2016, FDA published a proposed rule that amends the regulations regarding good laboratory practice (GLP) under 21 CFR part 58. GLPs must be followed by nonclinical laboratory safety studies that support or are intended to support applications for research or marketing permits for products regulated by FDA, including drugs. The proposed regulations center on changes related to data quality and multisite studies.
In December 2010, FDA published an advanced notice of proposed rulemaking (ANPRM) on these topics. More than five years later, the agency issued this proposed rule. FDA explains that the purpose of the rule is to ensure the quality and integrity of data derived from these nonclinical studies, and to integrate quality into planning, conducting, and reporting the studies.
The proposed rule’s main change is a new requirement that nonclinical studies subject to GLPs implement a complete quality system approach, or a “GLP Quality System.” Specifically, FDA defines this as “organizational structure, responsibilities, procedures, processes, and resources for implementing quality management in the conduct of a nonclinical laboratory study.” Although facets of the GLP Quality System are already included in the current regulations, to ensure that a complete system is implemented, FDA proposes new requirements relating to management responsibilities and standard operating procedures (SOPs) for ensuring the quality and integrity of the data. For instance, under the proposed rule, not only would management be responsible for establishing policy and objectives for the GLP Quality System, but they would also need to establish and maintain an adequate organization structure, e.g., personnel, resources, facilities, equipment, materials, and methodologies to ensure that all testing complies with the system. Additionally, management would be obligated to establish and update written SOPs, which would need to cover all applicable phases of a nonclinical laboratory study. Among other matters, SOPs would need to specify the procedures for 1) preparation, modification, and administration of SOPs 2) establishment and periodic review of a GLP Quality System, 3) Quality Assurance Unit (QAU) functions, including Quality Assurance oversight for multisite studies, and 4) multisite studies generally.
To better address the current prevalence of multisite studies, the agency also proposes to revise the definition of “testing facility” in the regulations. Currently, the definition is, in part, “a person who actually conducts a nonclinical laboratory study, i.e., actually uses the test article in a test system” and “encompasses only those operational units that are being or have been used to conduct nonclinical laboratory studies.” The proposed definition would instead define “testing facility” as “the person responsible for coordinating, conducting, or completing a nonclinical laboratory study, or any combination thereof. The testing facility designates the study director.” FDA explains that the new definition captures all possible contractual relationships in a multisite study. In a multisite study, the testing facility might not be the person treating the test system with the test article as the current definition specifies; the person treating the test system with the test article might be a contracted or subcontracted person.
Comments are due on November 22, 2016. The proposed rule is available here.