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tesis de grado
Publicado 2023
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The main objective this report is to explain the actions carried out in the process of qualifyin clean rooms within laboratory of the national production galenic products. This process is important because is a critical point within the Good Manufacturing Practices Manual (GMP), the same one that serves as a guide during inspections for Certification, Recertification and Inopinate Inspections, it is considered as a critical Non-conformity. The tests carried out during the qualification of the weighing room are Temperature and Humidity, which has as Technical Specification ≤ 30 °C and Humidity ≤ 80 %, results were obtained that were within the specification in each of the rooms that make up the weighing area. For the Light Intensity test, the specifications are: ≥ 500 Lux, for each of the points, obtaining 537 lux as the lowest average result and 583 lux as the highest result. Bein...