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Quality Assurance System
We operate under the GMP system, which corresponds to the cGMP protocol of the US FDA The GLP system is employed to conduct GLP studies such as toxicokinetic (TK) studies and specification tests for test compounds. Under the above systems, our aim is to improve SOPs and facilities/equipment so as to provide high quality data to our customers.
All study directors and chief analysts undergo an annual education/training program.
GMP Organization
Our GMP organization consists of a testing division, a sample storage & management division, and a quality assurance division. Studies are conducted according to study protocols, study operating instructions, and SOPs. Our QC and QA groups ensure the respective accuracy and comprehensiveness of data, and we aim to continually improve our quality assurance system so as to provide data in a speedy, reliable and accurate manner.
Quality Control/Quality Assurance
Studies are conducted in a reliable and accurate manner through the support and collaboration of both the quality control group and quality assurance group.
GLP Organization
Our GMP organization consists of a testing division, a sample storage & management division, and a quality assurance division. Studies are conducted according to study protocols, study operating instructions, and SOPs. Our QC and QA groups ensure the respective accuracy and comprehensiveness of data, and we aim to continually improve our quality assurance system so as to provide data in a speedy, reliable and accurate manner.
Results of Drug GLP Compliance Review
(by Organization for Pharmaceutical Safety and Research or Pharmaceuticals and Medical Devices Agency)
| Studies Inspected | Evaluation | Notification Date |
|---|---|---|
| Single, repeated dose toxicity, carcinogenicity, and genotoxicity studies (not including pathological examinations) |
Ａ | December 21, 1994 |
| Single dose, repeated dose toxicity, DART, genotoxicity studies, and irritation studies (not including pathological examinations) |
Ａ | March 12, 1998 |
| Toxicokinetics and genotoxicity studies (not including micronucleus studies) |
Ａ | December 27, 2000 |
| Toxicokinetics | Ａ | December 15, 2003 |
| Toxicokinetics | Ａ | June 15, 2007 |
| Toxicokinetics | Ａ | March 11, 2011 |
Education/Training System
Introductory training for new and mid-career employees includes a complete explanation of our company's activities and specialized practical training on analytic methods. As part of ongoing training, both internal and external training are conducted based on an individualized annual training program for each employee. We also maintain a database of training records so as to easily confirm the progress of each scientist in terms of education/training.
Based on our qualification system, scientists are only able to work in an area on receipt of certification for that area of operations, while scientists are certified to hold the position of Study Director or Chief Analyst by our qualification committee. Further, scientists are permitted to perform analyses only after appropriate training.