ADA to non-GLP

• Sus
  14/08/2020 07:58

  Has anyone considered conducting anti-drug analysis (ADA) in a GLP tox study as a non-GLP phase? More specifically using a GLP test site facility but with the ADA data as supportive data only and therefore removing the quality assurance inspection of the ADA phase. If you have considered and has experience with non-GLP ADA data, does the recent OECD GLP Position Paper Document no. 21 challenge your position? In this position paper, a non-GLP phase is described but only when a phase of the study is too technical difficult to be performed at a GLP facility. Of note, it should obviously be clearly stated how the ADA phase is conducted, that GLP is not claimed for ADA data, and use the wording ‘non-regulated’ in the tox protocol, the ADA phase report, the TK report and the main tox report.
• RQA GLP Committee
  11/09/2020 13:06

  Dear Sus, It is unclear as to why you wouldn’t want to conduct the ADA phase to GLP. As you say, it is easy to find a facility that can conduct this analysis to GLP. If it is because you haven’t sufficiently validated the method, or are having issues with validation or because you are trying to avoid a QA audit then this is not a valid reason to conduct this work Non-GLP. It would depend on how critical this analysis was to your study, and that you made it clear from the start of the study, but there doesn’t appear to be a good reason why your should not conduct this work to GLP if you can. if it is part of a regulated study then it should be conducted to GLP. However, if you are still at the investigative stage as to whether or not you suspect there to be an ADA then you might consider removing the samples from the study and conducting the work as a separate study.
• Susanne Gelvan
  07/10/2020 08:16

  The question is if the wording in consensus doc. 21 ('that non-GLP phases in a GLP-study is only OK if there are technically difficulties that cannot be overcome at a GLP facility') can be interpreted in the sense that if the ADA data is only supporting data, then it is acceptable to perform the phase to non-GLP?
• RQA GLP Committee
  19/11/2020 15:46

  Dear Sus, This does not seem a reasonable interpretation of the guidance. However, if you contact your monitoring or receiving authority and confirm that it is acceptable to them, then just be clear in the report and ensure that you do not claim compliance for the work.

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