Achievements

Decisions

Authorization to manufacture or import a medicinal product and an investigational medicinal product (product for clinical trials)

Continuously since 2004 MIKROLAB, as one of the first independent laboratories in Poland, specializes in pharmaceutical microbiology. Activities in this field are developed thanks to the GIF Permit for the manufacture or import of a medicinal product and an investigational medicinal product. In the light of the law, MIKROLAB is treated as a drug manufacturer, and employees of Mikrolab have the competences of qualified persons (QP), which are necessary in the process of inspecting medicinal products.

Authorization to manufacture or import a medicinal product and manufacture an investigational medicinal product - See more

Approval of the State Sanitary Inspection for water testing

MIKROLAB received the approval of the State Sanitary Inspection for water testing in 2011. The above Approval ensures that the tests of water intended for human consumption and swimming pool water are carried out using generally recognized norms, standards and testing procedures, and that water is collected by authorized samplers.

Approval of the State Sanitary Inspection for water testing. Thanks to the approval for water testing, the results are accepted by control authorities, i.e. Sanitary and Epidemiological Stations, Waterworks, etc.

Proficiency testing

From the beginning of its activity, Mikrolab has been actively participating in proficiency tests and inter-laboratory comparisons organized by accredited and leading domestic and foreign organizers. Mikrolab is also the organizer of inter-laboratory comparisons in the selected field of research.

Participation in these programs confirms the reliability of research results and the competence of the laboratory.
We also expect our suppliers to meet the same high quality standards. When choosing them, we follow clearly defined criteria. We inform suppliers about our quality assurance requirements, and their fulfillment is controlled through a system of reporting and audits.

PCA-certified

The PCA Certificate No. AB 1531 awarded by the Polish Center for Accreditation formally confirms the independence, competence, impartiality of the laboratory and compliance with the PN-EN ISO / IEC 17025 standard

PCA Certificate No. AB 1531 -See

Scope of accreditation No. AB 1531 - See

GMP certificate
In 2006, the leader of the Polish market in product research received the prestigious GMP Certificate issued by the Chief Pharmaceutical Inspector. The GMP certificate is a guarantee of compliance with Good Manufacturing Practices at every stage of the test, from accepting the sample to issuing the test report.

GMP Certificate - Medicinal products intended for humans

GMP certificate-Investigated medicinal products intended for humans

Achievements

Decisions

Authorization to manufacture or import a medicinal product and an investigational medicinal product (product for clinical trials)

Approval of the State Sanitary Inspection for water testing

Proficiency testing

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