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en:aree:fabiocell:sistema_qualita [2018/08/03 14:09] Gianluca Frustagli created |
en:aree:fabiocell:sistema_qualita [2019/05/16 01:59] (current) Gianluca Frustagli Hidden "to be revised" message. |
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| - | > FIXME **This page is not fully translated, yet.**\\ //(remove this paragraph once the translation is finished)// | + | **FaBioCell Area** |
| + | ====== The Quality System in the pharmaceutical context ====== | ||
| - | **Area FaBioCell** | + | Since its early stages, the development of a drug must adhere to an appropriate Quality System (SQ) aimed at __producing__ and __controlling__ the drug according to specific regulations and guidelines. |
| - | ====== Il Sistema di Qualità in ambito farmaceutico ====== | + | Quality Assurance (QA) is the function responsible for verifying the effectiveness of the Quality System. In Chapter 1 of the GMP the QA is described as follows: //"Quality Management is a wide-ranging concept, which covers all matters, which individually or collectively influences the quality of a product. It is the sum total of the organized arrangements made with the objective of the provision that the medicinal products are of the quality required for their intended use. Quality Management therefore incorporates Good Manufacturing Practice."// |
| - | Fin dalle fasi iniziali, si rende necessario applicare allo sviluppo di un farmaco un Sistema di Qualità (SQ) adeguato e mirato a __produrre__ e __controllare__ il farmaco secondo specifiche normative e linee guida. | + | At each of the different stages of drug development, from research phases to placing on the market, the application of specific "good practices" is required, as shown in the figure. Thus, Good Laboratory Practice (GLP) must be observed in preclinical analyzes, GMPs during production phases and Good Clinical Practice (GCP) during clinical trials. |
| - | L'Assicurazione di Qualità (QA) è la funzione preposta alla verifica dell'efficacia del Sistema di Qualità. Nel capitolo 1 delle GMP la QA viene così descritta: //"Quality Management is a wide-ranging concept, which covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use. Quality Management therefore incorporates Good Manufacturing Practice."// | + | \\ |
| - | A ciascuna delle diverse fasi dello sviluppo di un farmaco, dalla ricerca all'immissione in commercio, è richiesta l'applicazione delle "buone pratiche" specifiche, come mostrato in figura. Così, nelle analisi precliniche devono essere osservate le Good Laboratory Practice (GLP), nelle fasi di produzione le GMP e nelle fasi di sperimentazione clinica le Good Clinical Practice (GCP). | + | {{ :en:aree:fabiocell:sq.png |Quality system}} |
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| - | \\ | + | |
| - | {{ :aree:fabiocell:sq.png |Sistema di Qualità}} | + | /* > FIXME **To be revised.**\\ //(remove this paragraph once finished)// */ |
