ICH GCPエキスパート


MasterControl ICH GCP Expert Resources Include a Q&A Session a 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.

グローバル化が絶え間なく進むなか、ライフサイエンス業界の規制を1つの国にだけ適用し続けることはもう出来ません。世界市場全体に適用する必要があります。

日米EU医薬品規制調和国際会議(ICH)は、FDAと協力して、米国や日本、EUの規制機関にまで及ぶガイドラインを策定しました。ICH GCPを含むこのガイドラインにより、FDA規制コンプライアンスの形態が世界市場で活用されることが保証されます。

関連する動画を閲覧
無料リソースをダウンロード
コンテンツへアクセス

MasterControl Helps Companies Ensure Compliance with ICH GCP

MasterControl offers clinical quality management system (CQMS) solutions that are designed to help life sciences companies meet the requirements of ICH GCP.

Since 1993, MasterControl has been a leader in the quality management software industry. Today, MasterControl continues to use its extensive experience in the rigorous FDA and ISO environments to help companies around the world comprehensively 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.