On October 17, 2022, FDA revised two compliance programs related to FDA’s drug inspection program: CP 7346.832, which concerns Preapproval Inspections, and CP 7356.002, which concerns Drug Manufacturing Inspections. Compliance Programs (formerly called “compliance program guidance manuals”) are guidance to FDA staff performing inspections. They provide direction to investigators regarding specific topics to cover, questions to ask during inspections, and how to document observations.
FDA’s revisions include language focused on quality management maturity, indicating for the first time in the inspection programs that FDA investigators should assess the maturity of the quality management system above and beyond CGMP requirements in conducting inspections. For example, CP 7356.002 provides the following guidance to investigators regarding drug manufacturing surveillance inspections:
“Additionally, an inspection conducted under this compliance program provides an opportunity for investigators to observe and document examples of mature quality practices that exceed CGMP requirements and are indicative of an advanced quality system. To aid investigators, Attachment B provides some examples of these practices that, when properly implemented, are indicators of an advanced quality system. The information from this compliance program, when combined with information on mature quality practices gathered from other sources, provides FDA with a more comprehensive understanding of a firm’s quality system. This knowledge is used by the Agency to support regulatory decisions, including the use of more flexible approaches in our regulatory oversight.” CP 7356.002, at 19 (emphases added).
CP 7346.832 similarly indicates that preapproval inspections should provide FDA with an opportunity to assess the maturity of the quality management system and document examples that indicate whether the quality management system exceeds CGMP requirements. Importantly, FDA notes that this guidance concerns the evaluation of quality practices that exceed CGMP requirements, i.e., the applicable statutory and regulatory standards. It remains unclear how FDA investigators will document observations related to quality management maturity in the field. Given the relative novelty of quality maturity metrics as a subject for FDA inspection and the lack of clear instructions to FDA investigators, some stakeholders are concerned that investigators could use perceived deficiencies in the “maturity” of a site’s quality management system as the basis for a 483 citation or otherwise as supporting evidence for potential regulatory actions and decisions.
These changes in the surveillance and preapproval inspection compliance programs are in line with other recent actions taken by the Agency demonstrating its interest in quality management maturity. For example, in May 2022, FDA’s Office of Pharmaceutical Quality issued a white paper entitled “Quality Management Maturity: Essential for Stable U.S. Supply Chains of Quality Pharmaceuticals” and held a virtual workshop to explain FDA’s views on what constitutes a mature quality system.
FDA has also announced a meeting of its Pharmaceutical Science and Clinical Pharmacology Advisory Committee on November 2, 2022, to discuss quality management maturity. FDA explained as follows in the Advisory Committee (AdCom) agenda:
“[T]he committee will discuss the Center for Drug Evaluation and Research (CDER) Quality Management Maturity (QMM) program. QMM is the state attained when drug manufacturers have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement. CDER has proposed the development of a rating system that will help incentivize drug manufacturers to adopt more mature quality management practices at their facilities. The committee will consider the impact that a QMM program would have on the pharmaceutical industry, drug shortages, and supply chain resiliency. FDA will seek input to determine if experts from academia and industry support the development of a CDER QMM program to incentivize investments in mature quality management practices.”
https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-2-3-2022-pharmaceutical-science-and-clinical-pharmacology-advisory-committee-meeting. Stakeholders who may wish to pose specific questions, topics, or comments for discussion during the AdCom meeting may submit comments in advance of the meeting through November 1, 2022.
If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drugs, and Devices practice.
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