Implementation of Risk Assessment Tool for the Standardization of Training Methodology and Learning Assessments of Standard Operating Procedures in a Pharmaceutical Plant
Colón Galindo, Roberto
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The Food and Drug Administration requires that pharmaceutical companies submit to regular on-site inspections and product monitoring, and that they reveal the methods used in clinical trials proving drug efficacy. Thorough these companies are implementing Risk-Based approaches to quality. This focuses on higher elements, while reducing non-value activities. In addition companies are implementing lean approaches to minimize waste. One critical element are Standard Operating Procedures (SOP), which are the basic working instructions on how the employees will manufacture a drug product. SOPs are critical to efficient operations, quality control, and regulatory compliance. Beyond the written procedure, SOP compliance includes a requirement to train employees on essential job tasks. It is critical that employees who are performing Good manufacturing Practices (GMPs) tasks have received the relevant training via training method that ensures effective learning transfer. This project has been developed under the Quality Risk Management Model to develop and implement a tool for the Standardization of Training Methodology and Learning Assessments of SOPs in a Pharmaceutical Plant, in order to establish a standard process to determining the appropriate training methodology and assessment and identify and eliminate non-value-added training activities. Key Terms - Evaluation, Pharmaceutical Industry, Quality Risk Management, Standard Operating Procedures, Training Methodology.