Janice Berman, VP of Quality Assurance at Takeda Pharmaceuticals, has played a lead role in bringing together the Asia Working Group for the Washington-based non-profit. Berman told in-Pharmatechnologist.com, “We are forming a working group in China to provide the Asia-based representatives of current Rx-360 members, as well as new local members, the opportunity to network and learn from their peers, regarding Rx-360 related topics.”
The initial focus of the working group will be on audit offerings and supply chain security work, Berman said.
The Asia Working Group has a subteam focused on supply chain security, she added, noting that team will initially focus on topics addressed to date in existing Rx-360 white papers. The white papers include information on cargo theft risk assessments, how to combat illegal drug diversion, and other types of supply chain security management.
China, which has had issues in the past with chromium contamination and the safety of its heparin, will need all the help it can get in terms of protecting its supply chain as the country looks to become the second biggest pharma market in the world and the country’s supply chain becomes even more complicated.
Earlier this month, China's state Food and Drug Administration also warned about authenticity and quality of drugs sold online. But despite these issues, Berman said that recent problems were not a catalyst for the decision to form the working group.
Mirroring its work in the US and Europe, Rx-360 audits in Asia will “continue to follow the existing Rx-360 models, which, in the interest of reducing the audit burdens for companies, allow for one or more member companies to sponsor audits, and increase transparency into supply channels,” Berman said.
The company also recently selected BSI Supply Chain Solutions to help with its joint audit program and to ensure supplier compliance with quality and security standards through verification audits.
Rx-360 typically undertakes audits on behalf of member companies, though these audits are not expected to replace regulator audits of companies, Berman added. “To date, the Rx-360 joint audit program has received positive feedback from regulators. We look forward to highlighting the work being done by Rx-360 with a broad range of global regulators,” Berman said.
The US Federal Trade Commission previously praised the work of Rx-360, noting the consortium’s cost savings and safety enhancing benefits.
“We hope that additional supply chain security topics that are unique to Asia will be the topic of future Rx-360 white papers,” Berman added.
The Rx-360 Asia Working Group will hold an in-person meeting on June 25 in Shanghai, China, which will be an opportunity for companies to learn more about Rx-360 and its activities in China.