Dr. Alwin Sobe
Diapharm’s Dr. Alwin Sobe oversaw the restructuring of quality management from SFDA GMP to EU GMP guidelines at the Ningbo factory.
Pharmaceutical companies that are planning to launch medicinal products in the European Union which are manufactured abroad have to prove, amongst other things, that production complies with Europe’s Good Manufacturing Practice (EU GMP) guidelines. Therefore, contract manufacturers from other countries have to adapt their quality management to conform to EU standards. “While GMP rules are similar worldwide, a number of differences are found in the details,” stated Senior Manager GMP Services Dr. Alwin Sobe from Diapharm. He added, “Implementing EU GMP guidelines is therefore always a challenge.”
As a result, Neptune Pharma decided to bring experts from Europe on board when transitioning from Chinese SFDA GMP to EU GMP regulations. Over a period of several months, Diapharm helped to restructure the quality management system and to train employees in Ningbo.
“Thanks to the team’s efforts, we were able to secure the necessary manufacturing permit quickly,” commended CEO Adrian Endacott from Neptune Pharma. The Veterinary Medicines Directorate, a British supervisory authority, inspected the Chinese factory and officially confirmed the EU conformity of its production as part of the Trident authorisation procedure. Everything is now in place for the market launch in December.
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