The Quality System in the pharmaceutical context

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.

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.”

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.