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From left to right: Ruth Vellve, Laura Díaz Manel Alba, Sandra Gómez and Anna Domènech (Photo: PCB).

The analytical services CRO, Dekapenta Labs, obtains the GMP certification from AEMPS

Dekapenta Labs has just received the Good Manufacturing Practices (GMP) Certificate of Compliance from the Spanish Agency for Medicines and Medical Devices (AEMPS) as a laboratory for the quality control of medicines for human and veterinary use or in their research phase and which are manufactured and imported into the European Union.

Dekapenta Labs is a CRO (Contract Research Organisation) founded by the chemists Ruth Vellvé (CEO) with more than 18 years of experience in the pharmaceutical industry, seven of them as Director of the Analysis Department of a company in the sector, along with Anna Domènech (Analytical Development Technician), with experience in R&D and the validation and transfer of analytical methods using complex chromatography techniques.

Now, having obtained the GMP certification, Dekapenta will be able to offer physicochemical analytical services for quality control and the release of commercial batches of medicines within the European framework. And continue offering services for the development of new analytical methods; validations and transfers; nitrosamine analysis; stability tests for all types of pharmaceutical products; and in-use studies, among others, and all of them under the GMP environment.

In addition, the recent acquisition of a triple quadrupole detector (MS/MS) will enable Dekapenta to offer a wider range of services and provide maximum support in the determination of nitrosamines (common and derived), and unknown and toxicological impurities.

“The GMP certification is a significant achievement for the company given that, on one hand, it gives us access to customers whom, by regulation, need a GMP environment (both for themselves and for the laboratories they subcontract) and, on the other hand, it is also the recognition to our work quality, our traceability and the good practices carried out within the laboratory”, says Ruth Vellvé.

“Obtaining this GMP accreditation comes at a good time, as once all the bases are established and the internal procedures are defined, it allows us to focus on our commercial expansion, and let customers know everything that Dekapenta Labs can offer”, explains Anna Domènech.

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