QP Declaration: Conducting Clinical Trials in Europe with Drugs Manufactured in Non-EU Countries

Patricio Ledesma

Head Of Clinical Operations at Sofpromed

21 September, 2020

Biotech and pharma companies conducting clinical trials in Europe with a drug product (DP) manufactured in a non-EU country will need a Qualified Person’s (QP) Declaration when submitting the study to regulatory authorities.

What is a QP Declaration?

A QP Declaration is a document stating GMP compliance (equivalent to EU GMP) of an investigational medicinal product (IMP) manufactured in a non-EU member state (e.g. United States or China). 

Why is the QP Declaration necessary?

The QP Declaration is required when submitting a clinical trial application to a European national regulatory authority (e.g. AEMPS in Spain or AIFA in Italy).

If the IMP does not have a marketing authorization in the EU or an ICH country and is not manufactured in a European country, the QP Declaration is mandatory. 

The QP Declaration is a certification by a Qualified Person in the EU that the manufacturing of the drug product complies with GMP at least equivalent to the GMP expected in Europe. 

Where can I get an IMP QP Declaration template?

You can download a QP Declaration template in this link.

Which companies must be included in the QP Declaration?

The QP Declaration must include the companies involved in the drug product manufacturing (conversion of the API into the dosage form), packaging (primary and secondary), and labelling, as well as the laboratories in charge of stability and release testing.

On what basis is compliance with GMP (at least equivalent to EU GMP) verified?

The compliance with GMP at least equivalent to European standards must be verified on the basis of audits performed at the manufacturing site(s). This can be a personal onsite audit or an audit conducted by a third party.

If an audit of the site(s) has not been performed, the Qualified Person may provide an explanation on how he/she knows that standards at least equivalent to EU GMP were followed at the site (e.g. assessment of documentation provided by the manufacturer).

Will the regulatory authorities request audit reports for review?

Normally no, audit reports are not requested by regulatory authorities, as general rule. However, regulatory authorities may request audit reports for review if they have concerns about the processes implemented by the manufacturers. 

Is there a need to include active pharmaceutical ingredient (API) information in the QP Declaration?

No. There is no need for the API used in the drug product to be included in the IMP QP Declaration, but of course it is the manufacturer’s responsibility to ensure that the API has been fabricated according to high quality standards.

Are there different types of QP Declarations?

Yes. The specific QP Declaration discussed in this article is the one related to IMPs still under investigation (drug products to be used in clinical trials). This is the only declaration needed when submitting a clinical trial to regulatory authorities in Europe.

There is another type of QP Declaration, namely the one concerning GMP compliance of active substance manufacture, which is related to marketing authorizations (a different regulatory process). This declaration is not required when submitting a trial application (with IMP) to regulatory authorities. 

Who can issue a QP Declaration?

QP Declarations for drugs to be used in clinical trials must be issued by an authorized Qualified Person. 

The QP is normally a licensed pharmacist, biologist or chemist (or a person with similar qualification) who has several years of experience working in pharmaceutical manufacturing activities.

Please contact us at  info@sofpromed.com if you need a Qualified Person Declaration for your drug product.  

Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266  pledesma@sofpromed.com 

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Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266 pledesma@sofpromed.com