EU GMP Batch release testing
CoA/CoC for imported product release
Quality and Compliance with GMP Batch Release Service
Medicinal drug products imported into the European Economic Area (EEA) from third countries must be re-tested and certified by a Qualified Person (QP) for it to be released into the market.
Profarma offers such services as batch release testing and QP batch release. We can test chemical, biological, advanced therapies, vaccines, and other products. Our laboratory can handle all dosage forms such as oral solutions, solids, injectables, ointments, gels, powders, and others.
By choosing Profarma, you are partnering with a trusted leader in quality control testing, committed to delivering excellence at every stage. Let us help you navigate the complexities of regulatory requirements, so you can focus on what matters most—bringing safe and effective products to patients around the world.
EU GMP Batch Release Testing
Product chemical characterisation
- Identification tests (e.g., HPLC, UPLC, GC)
- Water content (KF)
- Assay (UPLC, HPLC, UV/VIS spectrophotometric method)
- Purity, related substances
- Gas Chromatography
- Thin Layer Chromatography
Product Physical Characterisation
- Solubility
- Loss on Drying
- Extractable volume
- Sulphated ash
- Osmolality
- Viscosity
- Gliding force
Microbiological and sterility testing
- Microbial contamination (TYMC/TAMC, and the absence of specific bacteria)
- Bacterial Endotoxins: LAL and kinetic chromogenic
- Sterility Testing
Dosage form and Container testing
- Dissolution/disintegration
- Hardness
- Friability
- Uniformity of dosage units
- Uniformity of mass
- Container closure integrity
- Leak test
Biological activity testing
- ELISA
- Bioassay
- Cell-based Bioassay
Frequently asked questions
We have our own QP, can we use Profarma for release testing?
Absolutely. In such a situation, Profarma will perform batch release testing and issue a Certificate of Analysis for your QP to further release the products.
How can I start working with Profarma?
Contact us today and our experts will be glad to discuss the next steps with you.
What documentation is required for batch release testing under EU GMP?
Our team will guide you through the complexities of the EU market and provide you with a detailed list of required documentation for release testing. It usually includes the final product specification and methods description.
Will I have a single point of contact to manage my projects at Profarma?
At Profarma we understand that registering and distributing your products in the EU can be challenging enough. Once you decide to work with Profarma you will get assigned a dedicated project coordinator who will be your main point of contact supported by the wider Profarma team.