Examination of a medicinal product manufacturing technology is a process within which is assessed the compliance of the technological processes used in the manufacture of a medicinal product with the requirements of regulatory documents. The review is carried out to ensure the safety and efficacy of the medicinal product for patients.
As part of the examination, an analysis of all stages of production is carried out - from the preparation of raw materials to the final packaging of the finished product. Experts assess the quality of the materials used, the compliance of technological processes with the requirements of GMP (Good Manufacturing Practices), the availability and observance of quality control procedures at each stage of production.
After the examination, a conclusion is made on the compliance of the production technology with the requirements of regulatory documents. If deficiencies are identified, then measures are taken to eliminate them in order to ensure the safety and effectiveness of the medicinal product.
it is necessary to estimate the time and cost of studies in order to prove the efficacy, safety and quality of the medicinal product. This may include Phase I to III studies in which the drug is tested in humans.
it is necessary to estimate the time frame for the development of a complete set of documentation for the medicinal product, including research results, data on production and quality, as well as information on its use and dosage.
To conduct regulatory expertise of a medicinal product, it is advisable to consult with the competent regulatory authorities that are involved in the registration and quality control of medicinal products. In Russia, these are the Federal Service for Surveillance in Healthcare (Roszdravnadzor) and the Ministry of Health.