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GMP manfacture for clinical trials in Asia

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  • McSweeney
    07/12/2020 10:46
    if a API for a clinical trial is manufacture outside the EU/UK for example in Aisa which have not undergo an FDA/MHRA/EMA inpsection what extra docuemntation would be required by a QP so that it can be used in a trial being conducted in the EU/UK? Also in the current climate if an audit is required at the site and this can not be done due to COVID-19 restrictions how are companies dealign with this issue?
  • Dominique Chesnais
    07/12/2020 12:00
    Please refer to an excellent blog produced by the MHRA about that topic at https://mhrainspectorate.blog.gov.uk/2016/05/20/manufacture-of-investigational-medicinal-products-frequently-asked-questions/ with some documents /links referred in it. About the Covid-19, an audit can still be performed remotely via video conference and with sharing of various documents for assessment of key requirements. However, a second one would be required when borders will be reopened.
  • Anthony Moult
    14/01/2021 16:19
    The committee would like to add to this comment that if and when a follow up would be required is likely to be highly variable depending on the circumstances. e.g. Any manufacturing activity from Master working cell bank establishment onwards, must be conducted to GMP and where such activities are performed in a “Third country” the QP must provide a declaration supporting the claim as the IMPD is filed. Ideally a report from an on-site audit would be available to support the claim but in the current situation, brought on by Covid-19, this is not always possible. A risk-based approach is therefore recommended. In a recent example of this we sat down with the certifying QP and worked through the information available to agree an approach. Information considered was: What is known about the facility from previous interactions Complexity of the task to be undertaken, Previous Health Authority history, Any issues from on-going interactions amongst other things. This was then used to inform the decision to take for each contractor but it can also be used to inform the decision as to whether an on-site audit will be required after a virtual audit and how soon. Another example - For a “simple” lab with a known history (previously audited) it was decided that the routine frequency was sufficient, but for a new complex manufacturing facility it was decided to schedule an audit “as soon as possible” - assuming we would be free to travel or could get an agent within the country to audit for us. It should also be noted that scheduling a follow-up audit may also be limited by the availability of the facility to host an event. Other Risk Mitigations measures may be relevant and it may be appropriate to build into a Virtual Audit report the recommended risk mitigation in conjunction with a shorter review period before reaudit “desk, remote or on site”.
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