Differences
This shows you the differences between two versions of the page.
| Next revision | Previous revision | ||
|
en:recycler:20250823-fabiocell:sistema_qualita [2018/08/03 14:09] Gianluca Frustagli created |
en:recycler:20250823-fabiocell:sistema_qualita [2025/08/26 18:25] (current) |
||
|---|---|---|---|
| Line 1: | Line 1: | ||
| - | > FIXME **This page is not fully translated, yet.**\\ //(remove this paragraph once the translation is finished)// | + | <WRAP center round important 60%> |
| + | **The FaBioCell cell factory __terminated__ its operations as of July 2025.** | ||
| + | </WRAP> | ||
| + | **FaBioCell Area** | ||
| - | **Area FaBioCell** | + | ====== The Quality System in the pharmaceutical context ====== |
| - | ====== Il Sistema di Qualità in ambito farmaceutico ====== | + | 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. |
| - | 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. | + | 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."// |
| - | 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."// | + | 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. |
| - | + | ||
| - | 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). | + | |
| \\ | \\ | ||
| - | {{ :aree:fabiocell:sq.png |Sistema di Qualità}} | + | {{ :en:recycler:20250823-fabiocell:sq.png |Quality system}} |
| + | |||
| + | /* > FIXME **To be revised.**\\ //(remove this paragraph once finished)// */ | ||
