Rx-360 creates Asia Working Group

The working group will focus its attention on identifying and mitigating root causes of quality problems and supply chain security

Rx-360, an international, non-profit supply chain consortium, has announced the formation of the Rx-360 Asia Working Group – India.

The working 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 working group held an initial face to face meeting in Mumbai, India on 24 February 2015. Meeting attendees were from global and local Indian pharmaceutical and supplier companies.

The Rx-360 Working Group - Asia has been active in Shanghai for almost 2 years. Given the size of India’s pharmaceutical market and its importance as a manufacturer and exporter of APIs and drug product to North America and Europe, Rx-360 believed it was important to also develop a presence in India.

The working group will focus its attention on identifying and mitigating root causes of quality problems and supply chain security. As a neutral, open and consensus building industry forum, Rx-360 seeks to help address these quality challenges and support India's 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 programmes among India-based suppliers and manufacturers
  • position Rx -360 as a mentoring resource for the Indian pharmaceutical 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. The survey is voluntary, confidential and anonymous. Results of the survey will be shared individually with participating companies. The intent of the survey is to gather benchmarking information to develop educational materials and other efforts that can help to advance data integrity understanding and mitigations.

Companies