Quality Assurance

INA provides reliable data of the highest quality for all studies.

Education

All study personnel receive periodic education on GLP regulations and experimental techniques.

Quality Control (QC) system

A thorough QC checking system is in place for the entire duration of all studies (GLP and non-GLP), including protocol preparation, study procedures and report preparation. Each technician and researcher double checks their own work, which is followed by further checks from their superiors and the study director. At the final report-writing stage, consistency with the raw data is checked by both researchers and the report preparation section.

Quality Assurance Unit (QAU)

Our QAU audits all GLP-compliant study protocols, raw data and related records and final reports, as well as carrying out on-site procedural checks during GLP studies to assure the reliability of data collected. Quality assurance statements are issued upon the completion of each study.

Inspections by regulatory authorities

Since 1985, INA has been periodically inspected by Japanese regulatory authorities (MHLW, PMDA, MAFF, etc.) for GLP compliance. Our high standards also conform with those required for applications to international regulatory authorities such as the FDA and EMEA.

Results of GLP Inspections

Inspections	Date of certification /strong>	Results
GLP for Pharmaceuticals	September 22, 1986	A
	July 6, 1989	A
	June 14, 1993	A
	November 14, 1996	A
	November 11, 1999	A
	November 19, 2002	A
	October 19, 2005	A
	October 1, 2008	A
	October 25, 2011	A
	November 26, 2014	A
	November 20, 2017	Complies
	January 22, 2021	Complies
GLP for Medical Devices	August 23, 2006	A
	October 1, 2008	A
	October 25, 2011	A
	November 26, 2014	A
	November 20, 2017	Complies
	January 22, 2021	Complies
GLP for Regenerative medicine	November 20, 2017	Complies
GLP for Regenerative medicine	January 22, 2021	Complies
GLP for Agrichemicals	April 3, 1989	Complies
	April 20, 1992	Complies
	April 5, 1995	Complies
	April 24, 1998	Complies
	August 13, 2002	Complies
	March 18, 2009	Complies
	January 16, 2018	Complies
	December 4, 2020	Complies
GLP for Chemical Substances	January 29, 1998	Complies
	February 3, 2000	Complies
	December 12, 2002	Complies
	November 30, 2005	Complies
	January 7, 2009	Complies
	November 15, 2011	Complies
	January 30, 2015	Complies
	January 9, 2018	Complies

GLP for pharmaceuticals/medical devices are graded A, B or C (A being the highest).

GLP for agrichemicals/chemical substances are graded “Complies” or “Non-complies”.