Quality Assurance

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 |
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”.