Technical Exchange and Training Seminar on Good Laboratory Practices (GLP)
China
On 5 and 6 November, the Certification and Accreditation Administration of the People’s Republic of China (CNCA) and the German Federal Ministry for Economic Affairs and Energy (BMWi) hosted the a technical exchange and training seminar on Good Laboratory Practices (GLP) in Guiyang. Organized by the Sino-German Quality Infrastructure Project and the China National Accreditation Service for Conformity Assessment (CNAS), the seminar served as a platform for representatives of Chinese testing institutions, inspectors, and international experts to gain a comprehensive overview of the current status of GLP in China. It also allowed participants to familiarize themselves with international standards and guidelines as well as organization and reporting procedures regarding study audits.
Moreover, potentials of harmonization of Chinese and international standards, particularly OECD guidelines, were discussed. In Q&A sessions with international experts, participants had the opportunities to engage in discussions on the challenges of joining the OECD Agreement on Mutual Acceptance of Data (MAD).
Long-standing partner of GIZ and head of GLP at the German Federal Institute for Risk Assessment, Dr Wolf Bulling, presented on GLP Study Audits and related procedures as well as the important role of sponsors and regulatory authorities. On the second day, a workshop was conducted under the guidance of Dr. Andrew Gray, Head of GLP Monitoring ath the British Medicines and Healthcare Products Regulatory Agency (MHRA), who addressed the key challenges and problems in the implementation of study audits.
In recent years, China has made significant progress in terms of GLP compliance. With the help of further reforms, this will continue with the goal of further aligning China’s GLP infrastructure with OECD standards.