Compliance with GLP standards and management in analytical laboratories: current status |
| |
Authors: | T Iwaoka |
| |
Institution: | (1) Research Institute of Sankyo, 1-2-58 Hiromachi, Shinagawa-ku, Tokyo, Japan 140 Tel.: +81 3 3492 3131 Fax: +81 3 5436 8569, JP |
| |
Abstract: | Analytical laboratories in Japan, operating more often as departments within a company than as independent contractors, have
to contend with different good laboratory practice (GLP) standards. Problems also occur in the analytical laboratories which
must comply with GLP, good manufacturing practice (GMP) and good clinical practice (GCP) regulations within the same facility.
The status of these GLP-complied analytical laboratories is reviewed with regard to assurance program, validation method,
laboratory information management, and security systems. The differences in the responsible authorities and scopes under the
six GLPs are also briefly described. Analytical tests in GLP are not itemized as a test for accreditation. Therefore, the
accreditation of analytical laboratories in Japan is currently granted as a part of ISO 9000 approvals.
Received: 27 September 1996 Accepted: 11 November 1996 |
| |
Keywords: | Analytical laboratories Good laboratory practice (GLP) Validation Good manufacturing practice (GMP) Accreditation |
本文献已被 SpringerLink 等数据库收录! |
|