QP Services from CSM
At CSM we have a genuine interest in the well being 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 CSM from any other clinical supply management company, through our QP services.
One of the advantages to working with us is the access to CSM’s two established sites in the post-Brexit EU. Our in-house QPs make your clinical trial risk free of any Brexit issues. Your QP is responsible for ensuring that the clinical product your study calls for has been manufactured and/or imported in accordance to EU GMP or equivalent satisfactions.
The CSM 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 to 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 authorizations and the CSM 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 CSM’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 reference throughout your clinical trial) needs have indeed been met and manufactured in accordance to 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. has 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 CSM’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.
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"I had some expectations of CSM, but you exceeded my expectations as you have amazing quality. The SOPs are well-written, easy to follow, and easy to understand."
VP of Regulatory Affairs, Biotech Company