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

Water Testing – Experience and Quality Confirmed by Accreditation

We perform water testing in accordance with applicable requirements and recognized testing standards. Sample collection is carried out by trained and authorized samplers.

We perform water testing for quality control, sanitary supervision, and water safety assessment.

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 certified

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

Number of tested samples
500000Number of tested samples
Audits of control authorities and clients
500Audits of control authorities and clients
Satisfied customers
15000Satisfied customers
Years of experience
30Years of experience

contact

Mikrolab sp z o.o.
ul. Lubelska 5/7
03-802 Warszawa
biuro@mikrolab.waw.pl
Tel.: 22 810 80 17

Water sampling
+48 732 080 317

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