QP Audits

Qualified Person Audits

In Europe no batch of medicinal product can be released for sale or supply prior to certification by a Qualified Person (QP) who is named on an MIA (Manufacturer’s/Importation Authorisation).

When a company contracts MIAS for a clinical trial or commercial batch certification, one of our first steps is to evaluate the GMP/GDP compliance status of each of the parties in the supply chain, from API manufacture through to transportation. Typically, this is done through what we term a ‘QP Audit’. These Audits may be performed by our QPs or by experienced auditors who have been approved by our QPs. When satisfactory compliance has been confirmed, we vary the relevant MIAS Pharma MIA to add your drug product and all relevant 3rd parties in the supply chain.

If you have an upcoming audit or would like to support our oversight and qualification of your suppliers, we have a European wide panel to support your project. Please contact us for more information.

Contact Mias

Qualified Person Audit Services

Supporting QP Services & Quality of your products in the marketplace.

THE MIAS APPROACH

At MIAS we apply a risk-based approach to performing Audits:

If you have an audit report of the relevant site(s) already available that is less than 3 years old, we will review that report. If the scope of the report reflects the scope of information required by the QP, and where the outcome of that audit indicates a satisfactory standard of GMP/GDP, we can accept that report and agree a timeline with you for a QP Audit.

On-site QP Audits, where indicated by the level of risk and as part of our site re-qualification programme to support continued batch certification.

Virtual hybrid QP Audits where we audit using audio visual technology to allow us to audit a site in real-time. This can be supplemented by our review of video recordings. This approach is complemented by a desk-based review of selected documentation and records that you make available to us through a shared site.