QP services

At Clinigen, we have a genuine interest in the wellbeing of others, providing clients with the highest level of standards, ethics, and quality.

We demonstrate our commitment to quality by consistently requiring stringent QA oversight, differentiating our Clinical Supplies Management team from any other clinical supply management company, through our Qualified Person (QP) services.

One of the advantages of working with us is access to our two established sites in the post-Brexit EU. Our in-house QPs can support both EU and UK drug product release and batch certification, mitigating any Brexit-related risk for your clinical trial. Your QP is responsible for ensuring that the clinical product your study calls for has been manufactured and/or imported in accordance with EU GMP or equivalent satisfactions.

The Clinigen process focuses on providing the best Qualified Person Services for your clinical trial supply needs.

QP services for clinical trials

A Qualified Person (QP) is primarily responsible for ensuring that the clinical product your study calls for has been manufactured and/or imported in accordance with EU GMP or equivalent satisfactions.

It is due to EU regulations that the manufacture of medicinal products, or importation from a third country, is subject to holding a Manufacturing and Importation Authorization.

The national competent authority of the Member State in which the manufacturer or importer operates, issues these authorisations and the Clinigen process focuses on upholding these standards while providing the best Qualified Person services for your clinical trial supplies.

This ultimately shortens timelines and reduces costs while improving overall quality.

It is important to note that all Qualified Persons and QP backup personnel are additionally available at Clinigen’s EU sites.

Specifics Regarding Our QP Services

  • QP Declaration: the process safeguarding your IMP (a pharmaceutical form of an active or placebo substance that is tested or used as a reference throughout your clinical trial) needs have indeed been met and manufactured in accordance with both your trial-specific processes as well as EU GMP standards.
  • Product Specification Files: simply a reference file, the PSFs contain all information necessary to draft the detailed written instructions on processing, packaging, quality control testing, batch release as well as the shipping of an investigational medicinal product.
  • QP Batch Confirmation: the process of providing a signed statement confirming, for instance, that the bottling of tablets, etc. have been conducted in accordance with EU GMP and PSF standards.
  • QP Batch Certification: the process of certifying in a register or otherwise equivalent form of documentation that, for example, final kits can be used in your study and within the EU, by a QP representing the quality of the batch’s release.

For more information regarding Clinigen’s exceptional QP service capabilities, read this Case Study to learn more about how we helped a Contract Manufacturing Organization (CMO) take an investigational medicinal product (IMP) into Europe.

Success stories

On behalf of my team, I would like to express our sincere thanks to Clinigen Clinical Supplies Management for your extraordinary work and dedication. We would not have been able to meet our clinical program goal without your heroic effort.

Vice President of Technical Operations

BioPharma company

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