Good Aseptic Manufacturing and New Technologies
Advancements in manufacturing environment and personnel training
Aseptic manufacturing of medicinal products has evolved rapidly over the last number of years, as a result of the development of numerous new applications and technologies. All of this is with the purpose of increasing the assurance of a safe medicinal product to reduce the risk to patients. Some examples of this development are the high-levels of automation and use of isolator technology, reducing the need for operator interventions, the use of automated systems to enhance repeatability and reliability of processes, real-time monitoring of processes or the environment to allow for direct data processing and interpretation, and the use of Virtual Reality (VR) for operator training purposes. To keep up with these technological advancements, regulations must also be updated or adapted to provide adequate guidance to manufacturers of new technologies and producers of pharmaceutical products and outline regulatory expectations when using novel technologies. One prime example of this was the publication of EudraLex Volume 4, Annex 1 “Manufacture of Sterile Medicinal products” in Aug 2022.