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Corporate office of Medis International a.s. in the Czech Republic is located in Prague; Production and Dispatching in Bolatice near Opava.

Medis International a.s.
Production plant Bolatice
Průmyslová 961/16
747 23 Bolatice
Czech Republic
tel.: +420 553 038 770
fax:+420 595 171 564
e-mail info@medisinternational.cz

Medis Bolatice

Quality Control and Quality Assurance

Quality control laboratories have been designed to meet the latest requirements of Good Manufacturing Practice for control of pharmaceuticals. They are equipped with the state-of-the-art analytical instruments enabling quality control of our products within the scope required by valid pharmacopoeias (PhEur, USP) and according to specifications which are parts of the registration documentation.

The physicochemical laboratory is equipped with two HPLC instruments AGILENT 1200 Series, dissolution apparatus SOTAX AT 7smart, tablet disintegrator SOTAX HT 10, dissolution testing unit SOTAX DT 2, UV spectroscope EVOLUTION 60-UV-Vis, balances Mettler, stability cabinets Binder and a unit for preparation of purified water Millipore MilliQ Integral 5.

The microbiological laboratory is equipped with a grade “A” clean room which enables qualified control of microbiological purity according the requirements of European Pharmacopoeia, and also control of sterility of parenterals. The laboratory is equipped with a Steritest Equinox by Millipore for testing of sterility, a kinetic reader Biotec ELx808IU for testing of endotoxins, sterilizers Astell and Binder and incubators Binder.

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Manufacturing and Distribution Authorization and GMP Certificate

Company Medis International a.s. is the holder of valid Manufacturing Authori-zation and GMP Certificate in the following scope:

1 MANUFACTURING OPERATIONS
1.5 Packaging

1.5.1 Primary packing
1.5.1.1 Capsules, hard shell
1.5.1.2 Capsules, soft shell
1.5.1.13 Tablets
1.5.2 Secondary packing
1.6 Quality control testing
1.6.1 Microbiological: sterility
1.6.2 Microbiological: non-sterility
1.6.3 Chemical/Physical
2 IMPORTATION OF MEDICINAL PRODUCTS
2.1 Quality control testing of imported medicinal products

2.1.1 Microbiological: sterility
2.1.2 Microbiological: non-sterility
2.1.3 Chemical/Physical
2.1 Batch certification of imported medicinal products
2.2.1 Sterile products
2.2.1.1 Aseptically prepared
2.2.1.2 Terminally sterilised
2.2.2 Non-sterile products

- GMP_certificate_Medis.pdf
- Manufacturing_authorization_Medis.pdf

Company is also the holder of valid Distribution Authorization.

- Povolení k distribuci.pdf