Healthy Skepticism Library item: 16187

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Taylor N.
Lilly to train Russian FDA
In-Pharma 2009 Aug 4
http://www.in-pharmatechnologist.com/Processing-QC/Lilly-to-train-Russian-FDA

Full text:

Eli Lilly is among the organisations partnering to provide training for the Rozdravnadzor, Russia’s equivalent of the FDA, which is seeking to improve its knowledge of manufacturing standards.
The partnership, which is made up of Lilly, the Chao Center and the Parenteral Drug Association (PDA), has been formed to spread global manufacturing standards throughout Russia.

In particular, training will aim to improve Rozdravnadzor’s understanding of good manufacturing practices (GMP). This also entails improving standards relating to pharmaceutical manufacturing technology and quality control.

Furthermore, the partnership hopes to increase dialogue between the regulator and other agencies, such as the US Food and Drug Administration (FDA).

By improving communication the partnership believes it can help spread understanding of laws and regulations related to pharmaceutical operations and inspections.

The partnership believes that these measures will help ensure the quality of medicines in Russia. Frank Deane, president of manufacturing operations at Lilly, added that “common global standards in pharmaceutical manufacturing are in the best interests of public health and patient safety”.

In addition, providing the training will bring benefits to Lilly, the Chao Center and PDA, according to Fionnuala Walsh, vice president of quality at Lilly.

Walsh explained that the programme with Rozdravnadzor will help Lilly fine-tune its own training practices in the US.

Improvements to in-house training help pharmas ensure “the quality and integrity of medicines that are manufactured and distributed in different countries”, which Walsh describes as a global challenge facing the industry.

The training programme

Officials from Rozdravnadzor and the Russian Inspectorate will attend hands on training sessions in the coming months.

These sessions will take place at manufacturing simulation facilities at Lilly, the Chao Center and the PDA in the US.