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Supply chain consortium establishes a working group to address quality problems in India.
Rx-360, an international, non-profit supply chain consortium, announced the formation of the Rx-360 Asia Working Group – India to identify and mitigate root causes of quality problems and supply chain security. The group will be led by Anish Swadi, vice-president, business development at Hikal; Huzefa Hussain, manager-quality assurance at Amgen; and Prashant Wani, senior supplier auditor at Eli Lilly & Company.
The Rx-360 Working Group - Asia has operated in Shanghai for two years. The organization reports that it developed a presence in India given the size of the pharma market and its importance as a manufacturer and exporter of APIs and drug product to North America and Europe. As a neutral, open, and consensus building industry forum, Rx-360 seeks to help address quality challenges and support India industry.
The working group's goals are to build Rx-360's reputation and credibility in India as a group with tools to solve problems relevant to the global pharma industry and supply chain; help understand and mitigate root causes of the most pressing quality challenges; share best practices and case studies from sites; spread awareness and understanding about Rx-360, its activities, and its audit programs, in India among India-based suppliers and manufacturers; and position Rx -360 as a mentoring resource for the India pharma industry.
The Rx-360 India Working Group has prepared a survey to solicit feedback from individuals who may have encountered data integrity (DI) issues in the course of their work in GMP sites located in India. The purpose of this survey is to benchmark experiences and mitigation strategies in order to develop educational materials and other efforts that can help to advance data integrity understanding and mitigations, the organization reports.