ICH GCP Expert


MasterControl White Paper Presents a Q&A session with Neil Wilkinson, Former EFPIA Topic Leader Within the ICH GCP Expert Working Group and Participant Creator of the ICH Q10 Pharmaceutical Quality System guidelines

With a continual increase in globalization, regulations in the life sciences industry can no longer stay specific to one country only; they must apply to the whole world market.

In collaboration with the FDA, the International Conference on Harmonization (ICH) developed guidelines that extend to regulatory agencies in the United States, Japan, and the European Union. These guidelines, including the ICH GCP, ensure that a form of FDA-regulated compliance is utilized in a worldwide market.

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MasterControl Helps Companies Ensure Compliance with ICH GCP

MasterControl offers a quality management software solution that can be applied in today's life sciences industry to meet the requirements of ICH GCP.

Since 1993, MasterControl has led the quality management software industry. Today, MasterControl continues to use their extensive experience in the rigorous FDA and ISO environments to ensure that companies around the world are able to easily meet the requirements of ICH GCP.

See how MasterControl's versatile and easy-to-use solutions can help the following specific industry niches:

  • Pharmaceutical
  • Medical Devices
  • Biotechnology
  • Blood/Tissue
  • Laboratories
  • Contract Organizations

ICH Q10 and ICH GCP

According to Wilkinson, ICH Q10 pharmaceutical quality system guidelines "...should help move pharmaceutical development and manufacturing and associated regulatory processes toward a much more science and risk-based way of operating." Other benefits of ICH Q10 implementation according to Wilkinson can also include the following:

  • Improved understanding of manufacturing
  • Improved manufacturing performance
  • Cost reduction in terms of internal failures
  • Cost reduction in terms of duplicate stock holding
  • Improved understanding of business processes
  • Improved performance of business processes
  • Improvement in relationships between regulators and industry
  • More risk-based elements

What is Your ICH GCP Strategy?

What is your ICH Q10 strategy? Have you read the Q10 guidelines and do you know what it could do for your company's bottom line? Consider not only the compliance benefits of ICH Q10 harmonization guidelines but the business process benefits.

For More Information About ICH GCP

For more information about GCP or ICH GCP, please feel free to contact a MasterControl representative.