Quality Assurance

• 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

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".