Drug Evaluation Committee 2012-01 Records to Assure Accuracy Control, etc. in Testing Laboratories
Related classification: Record keeping
First published: May 2012
Question
From April 2012, the sponsor will be required to confirm the accuracy control records of a laboratory. Are we obliged to keep such accuracy control records for the same period as the mandatory documents?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As stipulated in Article 4, Paragraph 1, Guidance 4 of the GCP, is it obligatory for a clinical trial sponsor to confirm that the laboratory (including laboratories, etc., of the implementing medical institution) has properly conducted the tests of specimens, etc. related to the clinical trial and that the accuracy control records of the laboratory have been properly maintained? As stipulated in Article 4, Paragraph 1, Guidance 4 of the GCP, in order to ensure that tests are conducted appropriately at laboratories (including laboratories at medical institutions) for specimens for clinical trials and that data pertaining to clinical trials are reliable, the sponsor must confirm records that guarantee accuracy control, etc. at such laboratories. In other words, the "records assuring accuracy control, etc." are important documents that support the reliability of the test data (original data), so these documents must be preserved during the period stipulated in Article 41, Paragraph 2 of the GCP.