An online training on Good Manufacturing Practices (GMP) was conducted for approx. 40 participants from the Pharmaceutical Sector in Armenia from 04.-05. December. Trainers were Dr. Dirk Feldmann and Dr. Daniel Meißner, both experts from internationally renowned pharmaceutical companies with extensive hands-on experience.
The importance of local production of medicines and medical devices in accordance with international quality standards becomes even more visible during the current global situation, which is dominated on the one hand by the Covid-19 pandemic and on the other hand by increasing number of worldwide conflicts. In this context the aseptic manufacturing of sterile products, e. g. vaccines, injectabilia, ophthalmics, plays an outstanding role for the development of an independent and sustainable health system.
In Armenia the pharmaceutical sector has been selected as value chain for the implementation of a CALIDENA project, aiming to improve QI-services in this value chain. Armenian partners are the Association of Pharmaceutical Manufacturers ArPharmA and the Scientific Centre of Drug and Medical Technologies Expertise as the National Regulatory Authority.
In order to enable pharmaceutical manufacturers in Armenia to produce sterile products under current Good Manufacturing Practices (cGMP) this training course provided a comprehensive overview of relevant aspects of modern aseptic manufacturing from legal requirements up to environmental monitoring combined with current examples of vaccine and ophthalmic manufacturing. The virtual training enabled the participants to learn the basics about the relevant guidelines, legal requirements, and ISO norms. Trainees became familiar with state-of-the art manufacturing lines of equipment for aseptic processes and manufacturing and with the control of the manufacturing environment. Classification and qualification of rooms and personnel was trained as well as the development and performance of media fills as important tool for validation of sterile manufacturing processes.
by Stefan Wallerath