A conference of the Eurasian section of ISPE was held on 16th–18th November in Moscow. It was dedicated to technical and technological innovations in pharmaceutical manufacturing. Akrikhin’s Quality Director Faiza Yagudina spoke at the panel session “Contract Manufacturing: Quality and Compliance Management”.
One of the central topics of the opening day at the conference was a session on contract manufacturing, where experts reviewed the experience of the Russian manufacturer in setting up proper interfaces with contract sites, discussed quality assurance issues and the documental aspect of the process. The topic of Faiza Yagudina’s speech was “Quality Agreements and Their Role in GM(D)P Compliance Assurance during Contract Manufacturing Set-up”.
High-quality contract manufacturing is what many world companies strive for nowadays. Manufacturing of products of adequate quality here fully depends on how the interfaces between the parties are arranged at all cooperation steps. Thus, at the preparation stage before production launch, it is critical to set forth in detail all the aspects of customer-contract site relationships in a quality agreement, to define the parties’ responsibilities, which lays the basis for subsequent efficient work. Participation in such conferences provides a possibility to exchange knowledge, gain international experience, take into account and apply up-to-date solutions and approaches in ones’ own practice,
– commented Akrikhin’s Quality Director Faiza Yagudina.
The second day of the event covered such issues as requirements for pharmaceuticals manufacturing, pharmaceutical engineering, design engineering and digitalization. The final day was held in the form of a tour of manufacturing sites in Kaluga.
The conference was attended by leading pharmaceutical experts, representatives of authorities and professional associations, and manufacturing companies from the EAEU and other countries. The participants discussed regulatory trends and novelties in the pharmaceutical area, and shared practical experience in the implementation of technical and technological innovations.