The 5th All-Russia GMP Conference was held online from September 30 to October 1. As part of this traditional forum, the speakers from major companies discussed the topical issues of the pharmaceutical and medical industries. Akrikhin joined the event as a session partner.
The COVID-19 pandemic has affected the pharmaceutical industry greatly, including the regulation and inspection of drug manufacturing processes. The general theme of the 5th anniversary GMP conference was focused on the development of mechanisms to regulate global processes during the pandemic and read as follows: “Unified GxP Rules – Quality as a Driver of Health”. The event took place in a distant format, which allowed expanding the coverage and involving experts from all over the world.
The day one business agenda included the key aspects of drug quality, availability and efficacy. The second day of the event was dedicated to an international workshop on GMP inspection. In 2020, the process of GMP certification was modified. Firstly, many companies who held a valid certificate have been given the possibility to extend its validity period by one year without any additional inspections. Secondly, the inspection format has also been changed, they are now conducted remotely, in accordance with international standards. In view of the changes, the conference raised some most critical topics, such as global cooperation, use of digital technology, the quality of drug development and storage, and many more.
Akrikhin acted as a session partner at the international workshop on GMP inspection. The speaker of the workshop’s training session was Olga Maklakova, Quality Director at Akrikhin, who spoke on “Remote Inspections: Experience and Results”. As an experienced expert, Olga shared up-to-date hands-on information about some specific aspects of conducting inspections at pharmaceutical sites in a remote format, including some peculiar features, possible challenges, and smart approaches to planning an inspection procedure.
Olga Maklakova, Quality Director at Akrikhin:
For Akrikhin, as well as for the entire pharmaceutical industry, the pandemic has turned to be a new challenge. Considering the restrictions imposed on physical site audits, the need for locking down some of the staff, and more complicated access to documents, it was important to respond to the new conditions promptly and effectively and re-establish communications by deploying digital technology for virtual demonstration of site availability for certifying conformity. Well-coordinated interaction between the site and the authorized representative, who was a connecting link between the inspector and the manufacturer, was critical. We were one of the first to carry out inspections in such a format and we do it well.