Quality management systems according to good development practices

At every stage of the development of new medicinal products, including the monitoring of their use in real life, in the name of protecting the health of each and every patient, the regulatory authorities have developed and control, and the industry applies and constantly improves rules that guarantee the use of quality, effective and safe medicines. These rules are known as good practices.

Good practices identify the best methods, techniques, processes, activities, etc., that are most effective in achieving a certain result, compared to other methods, techniques, etc.

Applying good practices ensures predictable and reproducible desired activity results, as well as fewer errors and unforeseen complications. Good practices have proven themselves over time and have been applied by many people and organizations successfully before becoming established as such.They are a standard that, depending on the type of sector in which they are applied, has a mandatory or recommended nature. Good practices help organizations prepare for effective (and not just formal) implementation of regulatory requirements, as well as increase their competitiveness and meet the increased demands of their customers. Good practice also means that organizations learn from those of them who are more successful and have achieved more (a process known as "benchmarking").

Originating as guidelines of a recommendatory nature, today most good practices in the pharmaceutical sector are mandatory in the form of normative documents (laws, regulations, guidelines, manuals, etc.). The good practices in the pharmaceutical sector prepared by the World Health Organization (WHO) the development of quality, safe and effective medicines (Good Clinical Practice - GCP, Good Laboratory Practice - GLP), the production of medicinal products under controlled conditions (Good Manufacturing Practice - GMP), as well as preserving the unchanged quality of medicinal products after leaving the territory, at the place of their production, until they are given to patients (Good Distribution Practice - GDP). The listed good practices in most countries are normatively imputed to drug manufacturers, marketing authorization holders and distributors.