About Us
Quality Assurance
Quality Assurance System
PMRJ has constructed, and is operating, a management system to correctly implement all of the work processes from direction by the MHLW to produce and distribute reference standards.
Quality testing is conducted by PMRJ and at least two other laboratories, and then approval as reference standards is obtained by the expert committee for reference standards evaluation, which is composed of external experts, on the basis of the test results.
Ensuring the reliability of test results
To ensure the reliability of its test results, The Pharmaceutical Reference Standards Center of PMRJ has obtained ISO/IEC 17025 laboratory accreditation, which serves as proof of the technical ability to carry out quality testing properly. In addition, we assures the reliability of quality test results by having multiple organizations perform quality testing and then comparing the test results among the organizations.
Maintaining and Improving Analytical Competence
By participating in proficiency testing sponsored by the European Directorate for the Quality of Medicines and Healthcare (EDQM), PMRJ has been striving to ensure that its ability in analytical technology is at the international level.
Participation record: Loss on drying, Water determination, Liquid chromatography,
Ultraviolet–visible spectrophotometry, Residue on ignition, Titration,
Thin-layer chromatography, Gas chromatography,
Polarimetry, Infrared absorption spectrophotometry, and others.
Initiatives for Development of JP and International Harmonization
As an associate member of the Japanese Pharmacopoeia Expert Committees of the Pharmaceuticals and Medical Devices Agency (PMDA), PMRJ participates in discussions on ensuring the quality and proper use of reference standards and is actively involved in the establishment, production, and distribution of new categories of reference standards. PMRJ also has been striving to understand international trends by interacting with the organizations that manufacture reference standards in Europe and the United States and by participating in international symposia and other such events.