Lilly, Chao Center, PDA partner with Russian officials to improve quality of global drug manufacturing, distribution

Lilly, Chao Center, PDA partner with Russian officials to improve quality of global drug manufacturing, distribution

INDIANAPOLIS and WEST LAFAYETTE, Ind. - A newly formed partnership that included participants from Eli Lilly and Co. and Purdue Research Park-based Chao Center provided training to the Russian agency that is equivalent to the U.S. Food and Drug Administration.

Lilly, the Chao Center for Industrial Pharmacy & Contract Manufacturing and the Parenteral Drug Association (PDA) partnered with health policy-makers from Rozdravnadzor in Moscow to conduct the training. Rozdravnadzor, the surveillance and inspection agency for medicines and medical supplies within Russia's Ministry of Healthcare and Social Development, is considered the country's equivalent to the FDA.

Goals for the training included improving Rozdravnadzor's knowledge of current Good Manufacturing Practices, advancing Russian standards for manufacturing pharmaceutical technology and quality control, and achieving an ongoing international dialogue between Rozdravnadzor and other regulators on laws and regulations in pharmaceutical operations and inspections.

The ultimate beneficiaries of this partnership are the patients utilizing pharmaceuticals in Russia, according to participants. 

"Common global standards in pharmaceutical manufacturing are in the best interests of public health and patient safety," said Frank Deane, Ph.D., president of manufacturing operations at Lilly. "Partnering with regulatory agencies and manufacturers is an important step toward achieving these standards."

Fionnuala Walsh, Ph.D., vice president of quality at Eli Lilly and Co., said sharing best practices with Russia and other countries not only will support meeting this challenge but also will help Lilly, the Chao Center and the PDA fine-tune their own training practices in the United States.

"One of the global challenges that pharmaceutical companies face is ensuring the quality and integrity of medicines that are manufactured and distributed in different countries," Walsh said.

The Chao Center manufactures and distributes the late-lifecycle drug Seromycin®, which is used to treat multidrug-resistant tuberculosis. The drug was developed by Lilly.  

"An important mission of the Chao Center is to teach future pharmaceutical scientists and drug manufacturers the production and distribution of late-lifecycle drugs," said Joseph B. Hornett, senior vice president, treasurer and COO of the Purdue Research Foundation, which manages the Chao Center. "One of the best ways we can do this is to make sure we provide a global experience for our students and for the people working in the Chao Center. We can take what we learn from our partnership with the Russian Inspectorate and incorporate it into our own training and educational programs."

Officials from the Russian Inspectorate and Rozdravnadzor are expected to participate in hands-on training in manufacturing simulation facilities at Lilly, the Chao Center in  Indiana, as well as the PDA in Bethesda, Md., in the coming months, said Hugh Sutherland, director of manufacturing and quality training and development at Lilly.

About PDA

The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 11,000 members worldwide.

About The Chao Center

The Chao Center for Industrial Pharmacy & Contract Manufacturing (http://www.thechaocenter.com) opened in 2005 at the Purdue Research Park of West Lafayette. Initiated through a donation to the Purdue University School of Pharmacy and Pharmaceutical Sciences from alumni Allen Chao, Ph.D., and his wife, Lee Hwa-Chao, the university-affiliated center is designed to provide a means to educate students in Good Manufacturing Practices (cGMP), provide pharmaceutical services to the pharmaceutical industry and provide an environment for Purdue faculty to conduct research in a cGMP facility.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at http://www.lilly.com.

Suggested Articles

Half of patients in an early trial of Allogene's off-the-shelf CAR-T cells for lymphoma who received a higher dose of its antibody ALLO-647 responded.

Takeda is tossing out a Shire pipeline med after it couldn't find a buyer.

Ipsen's new hire arrives at a company reeling from a torrent six months that have crushed hopes for its $1 billion bet on a rare disease drug.