To ensure the quality and reliability of data in a contracted non-clinical safety study subject to Good Laboratory Practice (GLP) regulations, the pharmaceutical manufacturer (sponsor) and the contract laboratory (contractor) must properly perform the duties and fulfil the responsibilities required
β¦ LIBER β¦
Symposium on Quality Assurance and Good Clinical Practice (GCP) in Cancer Drug Development
β Scribed by A. L. Kranich; G. Gastl; H. Maier-Lenz; G. A. Nagel
- Book ID
- 112498221
- Publisher
- Springer-Verlag
- Year
- 1994
- Tongue
- English
- Weight
- 375 KB
- Volume
- 120
- Category
- Article
- ISSN
- 1432-1335
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In Japan, Good Clinical Practice (GCP) was revised in 1997 to meet the standards of ICH-GCP. Along with the numerous requirements introduced with this new guideline, quality assurance (QA) is now far more emphasized than before, and a contract research organization (CRO) is legally recognized for th