en.Wedoany.com Reported - An evidence-based evaluation model for GMP inspectors (EBGMP, Evidence-based GMP) has been developed to address the gap in existing evaluation systems from the inspector's perspective. Previously, only an EBGMP evaluation model for filling systems based on the pharmaceutical enterprise perspective had been established in this field. This study aims to fill this gap and promote the application of evidence-based science in the GMP domain.
In GMP inspection practice, most clauses are only framework-level basic requirements, with actual enterprise behaviors varying widely. Inspectors face difficulties in making judgments when confronted with issues such as non-specific regulatory provisions, differences between domestic and international standards, and constraints imposed by the level of industry development. To address this, the research team constructed a complete EBGMP implementation pathway covering five stages: raising questions, retrieving evidence, evaluating evidence, applying evidence, and post-evaluation. The model categorizes difficult issues in GMP inspections into four types: issues arising from non-specific regulatory provisions, issues arising from differences between regulations, issues arising from constraints imposed by the level of industry development, and other types of issues.
In the evidence retrieval stage, the model recommends constructing or opening five major databases: a domestic GMP laws and regulations database, an international GMP laws and regulations database, a domestic GMP inspection database, an international GMP inspection database, and a literature database. The evidence evaluation stage classifies evidence into three levels based on authenticity, importance, and applicability: Level 1 includes high-quality validation studies, industry consensus, and explicit requirements from international regulations; Level 2 includes medium-quality validation studies and behavioral comparison studies; Level 3 includes low-quality validation studies, case reports, and expert opinions.
The evidence application stage requires combining the evaluated evidence with the specific circumstances of the enterprise to generate judgment results with four options: "critical deficiency," "major deficiency," "general deficiency," and "compliant," along with a pathway for enterprise feedback. The post-evaluation stage uses the effectiveness of enterprise corrective actions as an indicator, emphasizing the need for multiple inspectors and inspection agencies to jointly accumulate data to provide a basis for subsequent decision-making and regulatory revisions.
To achieve model intelligence, the research team envisioned an EBGMP Center. This center would be accessible via computer network platforms and mobile apps, allowing inspectors to complete the entire process from evidence retrieval to post-evaluation. Evaluation results, after review, can be published for reference by all inspectors, while a dedicated enterprise access pathway is established to facilitate information exchange while protecting enterprise rights. The research team emphasized that this model should not increase the burden on inspectors and should only be used for the aforementioned difficult issues. They also noted that GMP represents only the basic requirements for pharmaceutical production management, and for applications of new technologies that go beyond the existing regulatory framework, this model can be used for evaluation.
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