Calificación en Condición de Reposo de un Área de Fabricación de Formas Sólidas Farmacéuticas no Estériles de Baja Humedad en el Laboratorio AEB
Qualification in Rest Condition of an Area Of Manufacturing Of Solid Dosage Forms Not Sterile of Low Humidity In the AEB Laboratory The qualification is the action show documents to any area, system and equipment was properly installed or working properly according to the expected results. The valid...
Saved in:
| Published: |
2015
|
|---|---|
| Subjects: | |
| Online Access: | http://hdl.handle.net/10872/9463 |
| Tags: |
No Tags, Be the first to tag this record!
|
| Summary: | Qualification in Rest Condition of an Area Of Manufacturing Of Solid Dosage Forms Not Sterile of Low Humidity In the AEB Laboratory The qualification is the action show documents to any area, system and equipment was properly installed or working properly according to the expected results. The validation is the initial stage and this must be met in their entirety before validating processes to consider that a drug is safe and effective. The qualification must meet four stages before that can perform validation: Design Qualification (DQ), Installation Qualification (IQ), Operation Qualification (OQ) and Qualification Performance (PQ). This special work of grade (TEG) general objective was make the stage of Qualification Performance (PQ) in the areas of production of solid forms non-sterile low humidity, in the condition of rest, of the pharmaceutical company AEB, with the purpose to provide documented evidence that the areas and all its components could consistently operate in accordance with their specifications. The Qualification consisted of documents show that the critical parameters of physical and microbiological controls of the environment of the production areas were suitable for the manufacture of products and for the health of the staff. Two international standards were used to perform the work: 40 who report, annex 4, Supplementary guidelines on good manufacturing practices: validation, and standard ISO 14644-1-2-3-4. The Qualification was executed three days carrying out physical and microbiological tests daily. Then evaluated the results by applying mathematical statistics (numerical analysis), capacity studies and descriptive statistics, and can verify the compliance of the conditions of low humidity and other physical and microbiological tests in the areas. Subsequently was prepared the Report of Qualification, which approved the release of the areas to be used in all the manufacturing processes, in virtue of the results obtained documents showed that the environmental conditions of low humidity and other controls were maintained consistently guaranteeing in this way the quality of the processes to be developed and the conditions suitable for the product and personnel. |
|---|