title: Assay validation and technology transfer: problems and solutions.
abstract: In the industry of fine chemicals, including pharmaceutical and agricultural chemicals, analytical tests are performed by production departments or contract research organizations at some stage in the research and development of products. These external organizations are required to maintain the capabilities to perform analytical tests using methods that are equivalent to or better than those specified by analytical method validation. For this reason, transfer of analytical procedures to an alternative site becomes necessary. In this review, the relationship between transfer of analytical procedures and assay validation is introduced, focusing on analytical procedures that include HPLC.
authors.affiliation: Organic Synthesis Research Laboratory, Sumitomo Chemical Co. Ltd., 3-1-98, Kasugade-naka, Konohana-ku, Osaka 554-0022, Japan. Electronic address: okamotom@sc.sumitomo-chem.co.jp.
authors.forename: Masahiko
authors.initials: M
authors.lastname: Okamoto
mesh_terms: D002617:Chemical Industry / Q000379:methods; D002623:Chemistry Techniques, Analytical / Q000379:methods*; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D004345:Drug Industry / Q000379:methods; D012106:Research / Q000458:organization & administration; D012107:Research Design; D018581:Technology Transfer; D054928:Validation Studies as Topic
keywords: Comparative testing; Full validation; Partial validation; Revalidation; Validation