Test validity for the regulatory bodies
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You asked if your laboratory's use of a internal Standard test method will be valid for the regulatory bodies, even if you are not accredited.
I am not in the position to comment on specific regulations (e.g. FDA GMP) and can only comment from an ISO 17025 implementation and accreditation point of view. Performing a test is only a part of the overall management system requirements of ISO17025. The competency required to provide a consistently valid result is demonstrated through a number activities to meet the requirements of ISO 17025. Hence the importance of accreditation – the process of independent assessment and attestation to this competency.
I do not know what regulatory bodies you are referring to, nor the purpose of the test, i.e. type of product and application. Bear in mind the requirements may be different; for example if the test results were being used for quality control for a manufacturer, compared to studies for research or a product registration. As the laboratory, your responsibility is to understand, define and document the requirements for the work you do. Out of interest, I can mention that if the testing relates to alcohol-based hand sanitizer products during the COVID-19 pandemic; the FDA has issued a Temporary Policy for the preparation of certain products. See https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-temporary-policy-preparation-certain-alcohol-based-hand-sanitizer-products-during
I suggest you enquire as to the specific requirements of your customers (the use / purpose of the test result) and the requirements of their applicable regulatory bodies. ISO 17025:2017 clause 7.1 Review of requests, tenders and contracts and clause 7.2 Selection Verification and validation of methods are particularly relevant to your question. These are covered under section 09_Customer_Service and 10_Test_and_Calibration_Method in the ISO 17025 toolkit. https://advisera.com/17025academy/iso-17025-documentation-toolkit/
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Jun 04, 2020