Introduction. Currently at the international and national level there are public and private organizations, institutions and regulatory authorities, which work and cooperate with the pharmaceutical industry in order to achieve a consensus on the laws and rules of good medicine manufacturing practice. In this way, it is aim ed to achieve certain levels of quality, safety and effectiveness in the manufacture of sterile medicinal preparations necessary for health. Good manufacturing practice aim to promote human health and consequently improve the quality of life. Aim of the study. The paper aim ed to study the specifications stipulated to in the rules of good manufacturing practice in the field of sterile medicinal forms and manufactured under aseptic conditions. Material and methods. Analysis and studies of guidelines, medical and pharmaceutical journals of special use, Medline PubMed databases, regarding the good manufacturing practice of sterile pharmaceutical forms. Results. Good Manufacturing Practices (GMP) are guidelines that ensure the production, distribution and governance of a drug. It is a necessary condition for marketing authorization. The industry has its own characteristics and quality control systems for finished pharmaceuticals. The GMP system is considered the most reliable and proven quality assurance system for pharmaceutical products. When preparing sterile pharmaceutical forms, GMP technology is used, which allows their import and use in all countries of the world without any additional certification. The international GMP rules were adopted by the World Health Organization [1]. All the world's leading drug manufacturers must recognize and comply with GMP standards. Thanks to this system, it will be safe in the search of the population for a truly high-quality product that guarantees its effectiveness and authenticity. GMP protects the consumer from buying counterfeit, expired or useless goods. The production of sterile medicinal preparations provides special requirements to minimize the risk of contamination with microorganisms, particles and pyrogenic substances. Quality depends largely on the qualifications, training and conduct of the staff involved. Quality assurance is particularly important and this type of production must follow strictly established and validated manufacturing methods and procedures [2]. The production of sterile drugs must be carried out in a clean area accessible through hatches for personnel, equipment and materials. Clean areas must be maintained to appropriate standards of cleanliness and provided with air passing through filters of adequate efficiency. Products that are sterilized in terminal containers fall into the first category, and those that undergo some or all aseptic steps fall into the second category. Clean areas for the manufacture of sterile products are classified according to the characteristic requirements of the environment. All production facilities require a specific class of environmental cleanliness at the operational level to minimize the risk of microbial contamination. Conclusions. Good manufacturing practices are a compliance with various guidelines, guidance documents, directives issued and developed by international organizations and institutions, in collaboration with the pharmaceutical industry and several national regulatory authorities in different regions and countries, to guarantee the highest standards of efficacy, quality and safety in any process involving the manufacture of health products. By implementing the rules of good practice for the manufacture of sterile pharmaceutical forms, guarantee of the accessibility of pharmaceutical assistance with effective, qualitative and harmless medicines for the population.