Expanding GLP horizons
2016-10-25
JOINN recently hosted an inspection visit from the Korean Ministry of Food and Drug Safety (MFDS). The inspection, which took place at JOINN’s Beijing facility, was made in response to certain of JOINN’s sponsors having a need to submit pre-clinical data to the GLP monitoring authority in Korea. During their weeklong stay at JOINN, the inspection team covered study data in great detail, tracing each stage of data production and reviewing it for consistency, accuracy and integrity. JOINN are pretty confident that their facilities, people and data all stand up to detailed scrutiny and welcome any insights that external inspectors and auditing sponsors provide. The company is most pleased that all of the feedback was of a complimentary and informative nature.
JOINN recognises that the maturing of China-based pharma and biotech companies, with their potential markets becoming more internationalized, means that they are widening the countries to which they want to present data. As such, JOINN has made sure that its work is conducted in compliance with the major International GLP regulations. The company’s GLP systems and processes have been endorsed through a cycle of external audits by CDFA, US FDA, OECD (Poland) and now, the Korean FDA. Although there are more similarities than differences in the various GLP regulations, JOINN ensures that compliance with details of each relevant GLP is assured.
