Using dry runs to de-risk new packaging and device assembly lines Using Dry Runs to De-risk New Packaging and Device Assembly Lines Context In the highly regulated environments of pharmaceutical and medical device manufacturing, ensuring the efficacy and safety of products is paramount. Human factors simulation plays a critical role in this process, specifically through the use of dry runs, mock runs, and media fills. These techniques help to evaluate and mitigate risks associated with packaging and device assembly operations, addressing operator behavior and procedural adherence. Legal/Regulatory Basis In the United States, the FDA’s regulations found in 21 CFR Part…

Documenting Simulation Results in Validation and HF Files Documenting Simulation Results in Validation and HF Files In the realm of Regulatory Affairs (RA), particularly in the pharmaceutical and biotechnology industries, the documentation of human factors simulation results plays a crucial role in ensuring compliance with regulations and guidelines set forth by agencies such as the FDA, EMA, and MHRA. This article provides a structured guide for Kharma and regulatory professionals on the best practices for documenting simulation results, with a particular focus on validation and human factors (HF) files. Context of Human Factors Simulation in Validation The integration of human…

Cross-functional participation in HF-focused mock runs and drills Cross-functional participation in HF-focused mock runs and drills Human Factors (HF) engineering is a critical element in the pharmaceutical and medical device industries, focusing on understanding how operators interact with systems to enhance safety and efficacy. This is particularly important in aseptic processes where operator behavior can influence the outcome of production. Mock runs, media fills, and simulation-based training are key tools for validating human factors in real-world scenarios. This article serves as a regulatory explainer manual, detailing the relevant regulations, guidelines, and expectations surrounding human factors simulation and cross-functional participation in…

KPIs for Simulation Effectiveness and Operator Performance Uplift KPIs for Simulation Effectiveness and Operator Performance Uplift in Human Factors In the pharmaceutical and biotechnology sectors, ensuring operator competency is pivotal in maintaining quality and compliance. Human factors simulation plays a crucial role in validating processes that ensure safe and effective medicine production, particularly in aseptic environments. This article serves as a regulatory explainer manual designed for Kharma and regulatory professionals, focusing on key performance indicators (KPIs) for simulation effectiveness and operator performance uplift related to mock runs, media fills, and scenario-based training. Regulatory Context Human factors engineering (HFE) focuses on…

Global rollout of simulation-based HF training across sites Global rollout of simulation-based HF training across sites Context Human Factors (HF) is critical in ensuring the efficacy and safety of pharmaceutical products and medical devices. As regulatory agencies like the FDA, EMA, and MHRA increasingly emphasize the importance of human factors in their guidelines, the implementation of simulation-based training to enhance operator qualification becomes essential. This article serves as a comprehensive guide on how to effectively execute a global rollout of human factors simulation-based training across various sites, with an emphasis on the interaction with regulatory requirements, validation processes, and quality…