Statement of Retest Period / Shelf Life for test item: QA review and signature necessary?

• anon
  07/10/2020 13:43

  When a Statement of Retest Period / Shelf Life based on stability testing of the test item is generated, does (GLP)QA need to review and approve this Statement of Retest Period / Shelf life? According to OECD series on Principles of GLP n°19, the Study Director must have confidence in the procedures used to characterise the test item and be sure that the test item is what it purports to be. Test facility should be provided with information on the stability of the test item under storage and test conditions, or the test facility should determine such information. QA should perform inspections to verify the implementation of relevant procedures and practices, such as identification, storage, characterisation of test items. So I gather it is QA that needs to inspect the study documentation, including such statements of Retest Period / Shelf Life (and underlying processes) rather reviewing and signing such statements?
• RQA GLP Committee
  19/11/2020 16:33

  Dear Anon, As you say, it is the Study Directors responsibility to have confidence in the test item (and they should document their acceptance of the test item in the study data). QA will review this data at some point during the study – maybe at dose administration, maybe at report audit, but unless QA are working in the facility generating the C of A or re-test data then they will not be directly involved with approving such information. If the re-test data is not being conducted in a GLP facility then QA would not be necessary. QA should check that there is a process to ensure that someone (the SD) conducts the check, but they do not do it.

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