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PART 2 OF 3: The QP Role and Annex 16, Stability Data, and Audit Reports

QP Role and Process on Annex 16 and stability data

Following up on last week’s Top Clinical Supply QP Questions Asked At The 2017 Sherpa Summer Seminar blog post, below are additional scenarios that your clinical supply colleagues got answered by our expert QP panel at the Sherpa Summer Seminar.

After reading these, don’t forget to download our QP Cheat Sheet, 10 Things to Remember About the QP Process.


After Annex 16 came out, our QP asked us for audit reports from our vendors that we qualified. We pushed back that we can give them the audit certificate or statement, but not the report due to confidentiality agreements. What is your advice on navigating the Annex 16 requirement when it comes to the QP process?

This is a tricky situation because ultimately, the QP needs to be sufficiently aware of and confident in everything that is going on in your supply chain. He or she needs to have confidence around the quality standards that are actually in place at that particular site.  If a QP does not have access to audit reports for the different sites, how can he or she be familiar with those sites? An alternative is to have the QP or someone that the QP trusts to visit these sites themselves. While this may be a preference and recommended by certain member states and certain European country regulatory authorities, it is not a legal requirement that it is the QP that visits and audits the site. One way or another, the QP must have confidence in the entire supply chain be it through audit reports, or site visits.

How much does a QP’s involvement continue after release? Is there QP follow-up related to stability data? If there are protocol revisions, is the QP involved then?

It is the QP’s duty to ensure that the product is supplied to the patient in good quality. In Europe there are clinical supply retesting and expiry date requirements that often require stability and specification updates, so the QP’s role definitely does not end after the initial release or certification. If you are running an early phase trial, you will end up updating the stability and drug specifications, and the QP will need to be involved in that process. The QP’s role continues through to the end of the clinical trial, including details such as where any returned products should be stored until destruction.

The QP also gets involved in any complaints, any protocol changes, significant amendments to protocol that affect the clinical supply. If you have a new IMPD for example, the product will have a new expiration date that will need to be signed off on before labeling commences.

We often receive a request a few weeks before the first patient is expected in, asking for a QP release which sounds quite unreasonable. When is a good time to involve a QP and make sure you’re meeting your timelines?

At the very beginning. If you are planning to go to Europe, involve the QP as soon as possible. Each situation is unique, and the optimal point for the QP to be involved will vary depending on milestones such as whether an audit report is already available – and if so, what are the findings? If there is no audit report, then you need to dedicate some time to finding a QP who is available to conduct the report when needed.

Another point to keep in mind is that you will need to involve a QP when you write your IMPD because the stability program needs to be released by the QP.

Is leading stability data required for QP release? If we have leading data from either a platform product that’s very similar but not necessarily the same process can this be used or is leading stability data required from the exact same process? How much lead time is required?

Yes, it is required for QP release, and yes, the actual stability data does have to be from the exact same process. The lead time is something that you can potentially negotiate with the authorities. Required lead time depends on a few things: what clinical phase your study is at, whether your product is completely novel, or whether there is history from something similar that you can refer back to. Also keep in mind that just because the authorities may approve the stability data does not mean that the QP will automatically approve it. Make sure that your QP is involved in these conversations as well.

Next week, tune in for our final post in this three-part QP blog series, but in the meantime, don’t forget to download our QP Process Cheat Sheet:

 Download Sherpa's QP Process Cheat Sheet

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