SERVICES FOR PHARMACY AND HEALTH CARE

Pharmaceutical Quality control testing of drugs, medicines, medicinal products and adjuvans - for the producers and distributors of medicines.

In the field of testing and analysis of pharmaceutical samples, EL spol. s r.o. has many years professional and practical experience and qualified staff of accredited testing laboratories ensures their execution using modern laboratory instrumentation since 1996.

Tests of drugs, medicines, raw materials and adjuvans are carried out completely according to European Pharmacopoeia, national pharmacopoeias and valid standards at pharmaceutical practice (corporate standards of manufacturers, technical specifications, standard operating procedures of manufacturers).

Accredited testing laboratories EL spol. s r.o. also carry out pharmaceutical testing of manufactured or imported batches of medicines and drugs from third countries - analytical activity for manufacturers and importers for the purpose of releasing batches of medicinal products into the EU market. Based on the Test Report (Certificate of Analysis), the manufacturer or distributor may realise a batch release of produced or imported products from third countries on the area EU/EEA. Testing is performed according to Pharmacopoeia or according to manufacturer's documentation. Activity is carried out under a certificate of Good Manufacturing Practice – GMP compliance.

Laboratories hold a valid authorization from The National Institute for Drug Control to perform the tests - pharmaceutical testing of medicines, medical substances, medicinal products and excipients.

Tests and analysis of drugs, medicines, pharmaceutical raw materials and other samples are carried out on the bases of following documents:

  • CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER, issued by the State Institute for Drug Control, Certificate
    No.: SK/027V/2015
  • APPROVING DECREE, Approval No: Š-08/08 - State Institute for Drug Control - approves EL spol. s r.o. Division of Laboratory Services as a control laboratory to carry out pharmaceutical testing in the following fields:
    •  Pharmaceutical testing of medicines, drugs, medical substances, pharmaceutical products and adjuvans for human use and glass     packages for pharmaceutical use related with control and batch release of medicinal products on the area EU/EEA
    •  Reagent solution, volumetric and buffer solutions preparation and verification
    •  Aqua purificata testing
    •  Testing of infusion and dialysis solutions and water for their dilution
  • CERTIFICATE OF ACCREDITATION No. S-025, SNAS (Testing of samples and products, sampling)
  • STATEMENT OF GLP COMPLIANCE No. G-017 (Testing of samples and products)