Quality Assurance

Quality Assurance

Quality Assurance

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


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, 2017Complies
January 22, 2021 Complies
GLP for Regenerative medicine November 20, 2017 Complies
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, 2002Complies
November 30, 2005Complies
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”.