Good Laboratory Practice and Quality Assurance Activity in Japanese Contract Laboratories

Abstract

This paper briefly reviews the history of good laboratory practice (GLP) in Japan. It then covers results of questionnaires on why pharmaceutical companies use contract laboratories to conduct studies, and why they choose domestic over foreign laboratories. GLP standards related to contract studies are outlined. Sponsor inspections are described, including those at Taiho Pharmaceutical Co., Ltd. The quality of in-house studies versus those contracted out is examined.

Keywords

Good laboratory practice Quality assurance Contract laboratory Sponsor

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References

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Japanese Pharmaceutical Manufacturers’ Association. JPMA Drug Evaluation Committee No. 41; 1988.