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GLP Compliance Status

GLP (Good Laboratory Practice) provides standards for accurate and proper conduct of tests and studies that evaluate the safety of pharmaceuticals, medical devices, regenerative medicine products, agricultural chemicals, and chemical substances.

Kashima and Kumamoto Laboratories, Risk Assessment Center, and Shimura Laboratory of LSI Medience have undergone GLP compliance assessment of relevant regulatory authority, and provide highly reliable data for application for approval of pharmaceuticals, medical devices, regenerative medicine products, chemical substances, agricultural chemicals, Industrial Safety and Health Law, feed additives, and veterinary medicines, etc.

Kashima Laboratory

GLP Time Date of notification Judgement Next inspection
Pharmaceuticals First February 8, 1988 A Year 2021
Latest May 28, 2018 Pass
Medical device First May 28, 2018 Pass Year 2021
Chemical substances First December 8, 1988 Pass Year 2021
Latest June 26, 2018
Pass
Agricultural chemicals First August 3, 1987
Pass Year 2020
Latest February 12, 2019
Pass
Industrial Safety and Health Law First December 6, 1990
Approved To be judged based on the results of pharmaceutical and chemical substance GLP compliance inspections
Latest July 27, 2011
Approved
Feed additives First October 26, 1992 A *
Veterinary medicines First March 10, 2000 A *

*: Inspections will be performed when data of studies conducted at LSI Medience are used for application for approval by relevant authorities.

Kumamoto Laboratory

GLP Time Date of notification Judgement Next inspection
Pharmaceuticals First August 22, 1989 A Year 2021
Latest May 28, 2018 Pass
Medical device First August 23, 2006 A Year 2021
Latest May 28, 2018 Pass
Cellular- and tissue-based products First April 4, 2016 Pass Year 2021
Latest May 28, 2018 Pass
Chemical substances First July 21, 1994
Pass Year 2021
Latest June 29, 2018 Pass
Agricultural chemicals First April 20, 1992
Pass Year 2020
Latest February 12, 2019 Pass

Animal Welfare

New drugs, agricultural chemicals, and chemical substances are being developed to improve the welfare of all mankind. In order to evaluate their performance and safety, animal experimentation may be the only mean, and the outcomes of the animal experimentation make a tremendous contribution to the maintenance and promotion of human and animal health. Meanwhile, the animal experimentation requires life and physical burden of animals. It is necessary to implement the 3R "Refinement (less pain), Replacement (use of alternative methods), and Reduction (use of fewer animals)".

LSI Medience believes that animal welfare is the most important element in animal experimentation along with our utmost effort to implement 3R. We focus on strengthening environmental enrichment, improving housing environment of animals, and work to provide stress-free environments for the animals to improve the well-being of animals. All animal experiments conducted at Kashima and Kumamoto Laboratories are reviewed periodically by Institutional Animal Care and Use Committee, and the results are verified by AAALAC International.

AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care International) Accreditation

Nonclinical Research Center (Kashima and Kumamoto Laboratories) received accreditation from AAALAC International on November 6, 2012. Since then, we continue to maintain our accreditation status. We live up to our global responsibility for humanitarian care and use of animals and we conduct high quality research and studies at an international level.

AAALAC International an international non-governmental organization that promotes humane treatment of animals in science through voluntary assessment and accreditation programs. The AAALAC certification is globally recognized and valid.

AAALAC Certification plaque

AAALAC Certification plaque
AAALAC International
Date of accreditation

First: November 6, 2012
Second: June 28, 2016
Third: November 7, 2018

Facility inspection (Self-inspection) by institutional animal care and use committee (IACUC)

Latest self-inspection:
March 9, 2018; Result "Acceptable" (no major issue found)

In-house education
We provide education on animal welfare, occupational health and safety laws etc. to all staff regardless of profession.
New employee: Introductory education
All staff: Monthly education (once/month)
Memorial service

A memorial service is held annually at the Kashima and Kumamoto Laboratories.

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