PERFECȚIONAREA BAZELOR METODOLOGICE PENTRU SISTEMELE DE CONTROL MICROBIOLOGIC AL CALITĂȚII MEDICAMENTELOR

Summary. Microbiological quality control of drugs is an essential aspect for ensuring their safety and efficacy. The methodological bases of this control are constantly evolving, along with technological advances and the emergence of new challenges. At the current stage of development of the pharmaceutical industry and with the introduction of good manufacturing practices (GMP) and laboratory practices (GLP), approaches to the quality control of medicinal products (MD) and active substances are in a permanent dynamic change. The need to control the quality of drugs is also justified by the importance of ensuring their safety and effectiveness, with the reduction of the risks of adverse reactions when used by the consumer. “Quality must be benchmarked in the medicinal product” (Bracht K. 2004, Pharmaceutical cGMP 2002). Thus, starting with the development of new pharmaceutical products, at all stages from production to the consumer, it is necessary to assess the probability of the risk of releasing products of unconditional quality and to improve the control system to ensure their quality.Key words: methodological bases, microbiological control systems, drug quality, exploration, improvement.