Searched for QP release certificate? QP is short for Qualified Person. A QP states that together with the right documentations and compliances within the GMP manufacturing process, the company or factory in question will be handed a QP release certificate for the product in question. With that they can get approval for the operation and manufacture of products in third countries, that is sites that are located outside of the European Union boundaries, Switzerland, New Zealand, Norway and Japan. And therefore, subject to separate laws and rules depending on the country where the actual manufacturing takes place, as well as the laws governing importation to EU.

What is QP release certificate used for and how does it affect us?


The QP release is mandatory to your importation of products from third countries to EU, and to be able to carry on forward to clinical trials or with the marketing authorization of a new drug/medicinal product. If you are planning to renew your product, apply for a new one or do a change on your existing product, you will then have to be certified via the QP release certificate.

The QP release certificate will then go hand in hand with the other applicable manufacturing licenses. Such as the licenses required for importing products within EU.

How does the QP release certificate application work?


The application process for a QP release certificate will be accompanied by an application form. The application form will state the extension of the certificate, a clear definition, and what it touches upon.

The form is in separate parts, and each part must be fulfilled to be able to get the actual QP release certificate (this one is aimed at “third countries” – countries outside of the EU, Switzerland, New Zeeland, Norway and Japan.) In addition, you will also have to fill in the information asked in the form. You must state the address of the manufacturing site, the substances used or changed or other important certifications etc. ClinStorage can release products manufactured in third countries for you.

 

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