Validation of the technological process for the production of riamilovir-based solution for aerodispersible administration

Abstract

BACKGROUND: An important step in the production of riamilovir-based solution for inhalation administration is the validation of critical stages of the technological process. First, a detailed study of all production steps, from the preparation of the initial ingredients to the final packaging, is carried out. Control tests are then conducted, including measuring key process parameters and analyzing the physical and chemical properties of the solution. One of the important aspects of process validation is also the training of production personnel. Proper understanding and adherence to all process instructions and requirements ensures that the process is followed correctly. AIM: Carry out validation activities throughout the stages of the technological process for the production of a solution for inhalation administration based on the active substance “riamilovir”. MATERIALS AND METHODS: The study was carried out using the developed Pilot Industrial Regulations for the production of the medicina. The quality assessment of pharmaceutical substances, excipients and pilot samples was carried out in accordance with the requirements of the State Pharmacopoeia of the Russian Federation and GMP rules. RESULTS: It has been established that the technological scheme for the production of a solution based on the active substance “riamilovir” contains 6 main stages. The greatest risk is observed at the following stages: Auxiliary work 3. Obtaining water — risk of bacterial contamination. Тechnological process 4. Preparation and sterilizing filtration of the solution — risks of insufficient concentration and unsterility of the solution. Тechnological process 5. Dosing the solution into vials is a risk due to underfilling, as well as violation of sterility. CONCLUSION: Validation of the technological process of production of solution for inhalation administration based on the active substance “riamilovir” has been carried out. Critical stages in the technological production process have been identified. The optimal parameters of the technological process have been determined and documented, leading to a predictable result — the release of a high-quality and safe drug. © Eco-Vector, 2024.