Given the restrictions related to free travel and conduction of in-person events, a number of decisions have been made aimed to overcome the barriers by preserving, however, a high level of compliance with the Good Manufacturing Practices. Thus, for instance, the Russian Government allowed a one-year prolongation of GMP certificates that were to expire in 2020. Similar measures were undertaken around the world. Apart from that, the format of remote inspections was introduced within a short period of time and has basically become a standard for the moment. The matters of international cooperation are being actively discussed. Industry representatives note that given these new conditions the regulatory authorities of various countries have to acknowledge the examination and inspection results on a mutual basis. Another aspect of these changes is the need for a more active exploitation of digital technologies, innovative software and algorithms that will allow to conduct efficient and transparent GMP inspections with account for all nuances. Considering all this, the staff of pharmaceutical companies has to be willing to study and adapt the new schemes. Thus, the second day of the V All-Russian GMP Conference will be dedicated to the new GMP inspection formats. AKRIKHIN Company is the session partner. Last year at the event in Svetlogorsk, a report titled Re-Inspection of Production Sites: Development of CAPA Plans and Their Implementation presented by Olga Maklakova, QA Director at AKRIKHIN, excited a great interest. Olga Maklakova possesses the expertise and an extensive experience and this year she will share practical information on the specifics of conducting pharmaceutical inspections in these new conditions, i.e. remotely. What nuances are there? What difficulties can one face? How should the inspection procedure be structured? All these questions will be addressed in the presentation Remote Inspection Given the Restrictions of Production Site Visits by the AKRIKHIN expert.
Olga Maklakova, QA Director at AKRIKHIN, “Since the conduction of field audits at the production sites is now limited and some personnel has been placed in self-isolation, it is very important to quickly and efficiently respond to this new challenge and to restructure communications using digital technologies and virtual demonstration of the commitment to validate conformity. In our case, we have managed to implement this inspection method successfully both on the part of the supervisor and on the part of the manufacturer and its authorized representative.”
You can see the detailed master class program on the website.