원문정보
초록
영어
The purpose of any analytical measurement is to get consistent, reliable and accurate data. There is no doubt that incorrect measurement results can lead to tremendous costs. If pharmaceuticals with incorrectly measured specfications (eg. inadequate assay, efficacy) are marketed, it may have to recalled. If pharmaceuticals with undetected impurities are distributed, they can have negative impact on people"s health. In addition, reporting incorrect analytical results can leads to loss of a laboratory"s confidence in the validity of future results.
Therefore, any laboratory should report the results using accurate and reliable data with art state technology. GMP system including validation and qualification in analytical laboratory will help to achieve this goal. In GMP(Good manufacturing practice), GCP(Good Clinical practice), GLP(Good Laboratory Practice), validation of analytical method, equipment qualifiacition, adequate documentation system and traceability should be required.