EL spol. s r.o. (EL) is approved by the competent authority of the Slovak Republic (State Institute for Drug Control - ŠÚKL) as a Quality Control laboratory for conducting pharmaceutical testing of drugs for human use (Manufacturer's Authorisation V-23/2020).
ŠÚKL assesses the compliance of EL's activities with the principles of Good Manufacturing Practice during regular inspections and confirms by issuing a Certificate of GMP Compliance.
Based on the approval of ŠÚKL, the following activities are performed in EL:
Pharmaceutical testing for manufacturers / importers of medicinal products:
- quality control of medicines in order to release batches of medicines into the EU area
- stability testing of medicinal products
Services for pharmacies and dialysis centres:
- quality control of purified water (Aqua Purificata) prepared in pharmacies
- quality control of the water used to dilute dialysis solutions
The tests are performed according to the current version of the pharmacopoeia or according to the methods provided by the customer.
- Medicinal products - drugs
- Pharmaceutical raw materials
- Active and auxiliary pharmaceutical ingredients
- Packaging for pharmaceutical products
- Waters for pharmaceutical purposes
Areas of quality control testing:
- Chemical / physical
- Microbiological, including sterility testing
EL is a control laboratory registered and audited by the US Food and Drug Administration (FDA).
EL is approved as a control laboratory also by the Institute for State Control of Veterinary Biologicals and Medicaments (ÚŠKVBL) of the Slovak Republic and is a holder of the Certificate of GMP Compliance for quality control of Veterinary Medicines