CHMB16H3 Lecture Notes - Lecture 2: Phenolphthalein, Atomic Mass, Volumetric Flask
Document Summary
History: glp is a formal regulation that was created by the fda in 1978, used world-wide now, started in the u. s. a, in 1981, oecd (organization for economic co-operation and development ) produced glp principles that are international standard. Objectives of glp: glp makes sure that the data submitted are a true reflection of the results that are obtained during the study, makes sure data is traceable, promotes international acceptance of tests. Mission of glp: test systems, archiving of records and materials, apparatus, material and reagent facilities, qa programs, performance of the study, reporting study results, standard operating procedures (sop, personnel and test facility organization. 1: definition of raw data, keeping records, reporting, storage, mixing and retrieval of data. Statistical procedures for data evaluation: practitioners in a particular field may adopt certain standards which are deemed acceptable within their field statistical procedures are not just chosen from a textbook, regulatory agencies often describe acceptable statistical procedures.