Drug Evaluation Committee 2011-34 Records Assuring Accuracy Control in Testing Laboratories
Related classification: Other
First published: December 2011
Question
The GCP notice of operation was revised* to state that "In order to ensure that tests are conducted properly at laboratories for specimens related to clinical trials and that data related to clinical trials are reliable, the sponsor or person who conducts the clinical trial himself/herself shall confirm the accuracy control, etc. at the relevant laboratory. I would like to know the specific items (contents) that the medical institution should respond to this.
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As of December 2023Revision to the "Implementation of the Standards for Conducting Clinical Trials of Pharmaceuticals (October 24, 2011, Pharmaceutical Affairs Bureau, Food and Drug Administration, No. 1024, No. 1)".
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The content of your question is also stated in GCP Article 4, Paragraph 1, Guidance 4, but it does not specify the specific details and items to be checked by the sponsor or the person who conducts the clinical trial. As stated in the Guidance, the scope of accuracy control and other necessary checks and specific check methods are to be agreed upon between the sponsor and the site, taking into consideration the position of each test data in the relevant clinical trial (e.g., whether it is a major endpoint or not).
In ICH GCP, 8.2.12 and 8.3.7 as 8. ESSENTIAL DOCUMENTS state "To document competence of facility to perform the required test(s) , and support reliability of results" (the required laboratory test(s)). To document competence of facility to perform required test(s) , and support reliability of results" in 8.2.12 and 8.3.7, as "To document competence of facility to perform required test(s) , and support reliability of results", which includes certification, accreditation, established quality control and/or external quality assessment (e.g., "established quality control"). The following documents are listed as examples: certification, accreditation, established quality control and/or external quality assessment, and other validation (where required).
Therefore, it is recommended that documents and records that can support the eligibility of the testing equipment and the reliability of test results be prepared and provided to the sponsor or the person conducting the clinical trial for inspection, etc.
Reason for revision of opinion
With the issuance of the GCP Guidance (December 28, 2012, Pharmaceutical Affairs Agency, Food and Drug Administration, No. 1228, Issue 7), we have added an explanation of the scope of accuracy control, etc. that need to be confirmed and the method of confirmation.