Types of certification

As part of Mitsubishi Chemical Medience’s drug development services (Bioanalysis Service and Central Lab Service) the company has acquired certification in the global-level ISO9001 standard for quality control systems.

Together with looking to clarify responsibility and jurisdiction in the testing process, we are also involved in standardizing test technology and looking to provide test results that are accurate, trustworthy and based on the strictest standards of quality control.

NGSP

Mitsubishi Chemical Medience’s dedicated clinical testing laboratory (C-Lab) acquired the international standard of Level 1 Laboratory status for HbA1c testing from the U.S. National Glycohemoglobin Standardization Program (NGSP) in January 2006. The lab is currently the only such facility in Japan to have received this globally-recognized certification.

Measurements involved in HbA1c testing are currently undergoing attempts at standardization within Japan through the efforts of the Japan Diabetes Society (JDS). Recent years have also witnessed increased efforts towards use of globally recognized values in this field by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). Despite these efforts, however, NGSP is still recognized as the globally recognized standard in North America and Europe, and all of these figures do correlate with one another.

NGSP accreditation is held by the majority of laboratories involved in clinical testing in North America and Europe, and the acquisition of Level 1 certification by the company’s C-lab means that we can handle requests for clinical testing from both international and domestic clients from within Japan.

• The Central Lab Service’s overall operations are based on a structure rooted in Good Clinical Practice (GCP), and an study coordinator has been appointed for each protocol, allowing the company to carry out operations in this area with a high sense of accountability.
• Clinical laboratory testing is carried out based on a range of strict control standards, based on CAP and ISO15189
  For details
• We provide an independent audit section dedicated to monitoring clinical testing in order to fully meet the high standards required in carrying out clinical laboratory testing

GLP (Clinical Trial Service Division and Toxicological Science Division)

GLP (Good Laboratory Practice) refers to the Ministerial Ordinance for Standards of non-clinical study on pharmaceutical safety, which is based on regulations stipulated within the Pharmaceutical Affairs Law. At the company’s Drug Analysis Center, Kashima Laboratory, and Kumamoto Laboratory, we ensure confirmation of type-A evaluation to confirm safety in line with the Pharmaceuticals and Medical Devices Agency. Within the field of drug development service the company is able to provide test data that is of the highest possible standard.

We also perform all the safety studies in compliance with the various GLP regulations such as the Industrial Safety and Health Law, Chemical Substances Control Law, Agrochemicals, OECD, etc. at the Kashima Laboratory, Kumamoto Laboratory, and Yokohama Laboratory.

Recent GLP Inspections and Results (Year: Judgment) of Toxicological Science Division

Ministry of Health, Labour and Welfare			Ministry of Economy, Trade and Industry
Pharmaceuticals	Chemical Substances	Industrial Safety and Health Law	Chemical Substances Control Law
2008 Kashima: A	2008 Kashima: pass	2008 Kashima: pass	2006 Yokohama: approved
2009 Kumamoto: A*	2009 Kumamoto: pass

Ministry of Agriculture, Forestry and Fisheries
Pesticides	Feed Additive	Veterinary Medicine	Physical and Chemical Property
2008 Yokohama: approved Kashima: approved Kumamoto: approved	1992 Kashima: A	2000 Kashima: A	2008 Yokohama: approved

*:

including medical devices

Ministry of the Environment
Chemical Substances Control Law
2006 Yokohama: approved

We have also implemented an audit system using a dedicated audit team that looks at every stage of this process, from initial preparation to storage of data, materials, and samples.