You're striving for efficient sample processing. How do you ensure quality control measures are maintained?

Com certeza treinar os analistas nas atividades gerais de uma laboratório e os responsáveis por realizar as amostragens em seus respectivos procedimentos. Outros fatores importantes para garantir a correta avalia??o das amostras s?o métodos devidamente validados e equipamentos qualificados e calibrados.

Getting a good quality result starts from when samples are being collected. Make sure samples are collected in the appropriate container and maintain at the required temperature from collection site up till the samples are processed or analyzed. Due process must be followed, and this include adhering strictly to the SOPs, in other to get a good result

Es también importante, en mi experiencia, la validación de los métodos de todos los métodos de análisis. Por otro lado, tener en cuenta que para poder garantizar la calidad de los productos a controlar, las auditorías al sistema de calidad le dan a las organizaciones la posibilidad de mantenerse en estado de mejora continua.

Sample collection is a key and first barrier to cross to ensure quality control of results. As long as the implemented SOPs are followed it should be quite simple to overcome any defects that may cause quality of work to be affected.

Considero que es importante realizar la capacitación amena y didáctica, donde se puedan expresar las dudas y se puedan realizar observaciones. Muchas veces se descubren hábitos incorrectos o mal entendidos durante las capacitaciones, en mi experiencia, de mucho tiempo.

Training in a GMP environment is essential for ensuring that employees understand and adhere to the rigorous standards required for the production of pharmaceuticals, medical devices, and other regulated products. GMP guidelines are designed to ensure that products are consistently produced and controlled according to quality standards. Training in this context focuses on a wide range of topics to ensure compliance and maintain product safety for the patient. Instructors should provide theoretical knowledge through lectures and presentations.On-the-Job Training in the actual work environment, where employees apply GMP principles under supervision. Online courses to reinforce GMP concepts. Assessments and Certifications.

A mí me ha tocado capacitar a varios de mis compa?eros, y creo que es importante, además de la capacitación y la evaluación de los conocimientos adquiridos, el entrenamiento, y el seguimiento de las técnicas y procedimientos en cuestión. De manera que el dise?o de los contenidos, es tan importante cómo el método de practica elegido en el procedimiento de capacitación.

Instrumentation is often overlooked when looking at quality. While SOP’s are written, methodology and metrology are accounted for, the user experience when interfacing with these analytical tools can significantly impact how a quality team is managed. Imparting even a small understanding of how samples are analyzed is critical to continuous improvement of daily operations. While calibration and validation are essential for batch reproducibility, this unavoidable process is cornerstone for teaching analysts how to spot inconsistencies in data. This thought process requires a higher degree of understanding as to what happened during the analytical process that may have caused any outlying data points.

This is where an AI algorithm could be useful in determining specific deviations that are individual for data entry clerks in nature. Also, scanning paperwork and having the AI populate fields and highlighting the area of the scanned paperwork that correspond to the field makes it easier for the data entry clerk to make corrections if needed. The risk is that the data entry clerk may get complacent. A personal reward system of recognition monthly of a certain % processed correctly may decrease complacency.

Mi experiencia en la supervisión de procesos se remite a la elaboración y control de cartas de control, de estándar y controles internos. En el proceso de validación de las técnicas, se establecen parámetros de control para los estándares y control internos, y ésto permite, que cada vez que existen desvíos en el procedimiento quedan reflejados en las cartas de control y validados los resultados contra los controles internos. ésta información es crucial en las investigaciones que se originan por OOT ú OOS según corresponda.