A traditional cycle of lectures from OCTAPHARMA-PHARMIMEX LLC took place in in the Ryazan State Medical University
2024-01-25Employees of OCTAPHARMA-PHARMIMEX LLC held lectures for students of the Ryazan State Medical University. In addition to traditional lectures from employees of quality assurance and quality control departments, this year representatives of aseptic production department and production operations support department joined the lectures. During the sessions, the students were introduced to the general structure of a large pharmaceutical organization and production. The concept of asepsis, clean rooms, technical design of clean rooms, aseptic filling lines and RABS systems were discussed in detail, methods of microbiological sampling were shown, and practice on changing clothes in clean areas was conducted. Then the students were introduced to the organizational and functional structure of the quality control department, the microbiological laboratory and the methods used in it, conducted a practical training on filling in the protocols of analysis with demonstration of Petri dishes with bacterial culture growth, introduced to the concepts of "Qualification" and "Validation", as well as the main norms governing these processes in pharmaceutical production. Special attention was paid to practical examples of qualification and validation activities. In addition, the students had the opportunity to familiarize themselves with examples of monitoring and trending, which are important elements in ensuring the proper implementation of the stages of production of medicinal preparations.