1S5medic - Microbact AG

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CERTIFICATE OF GMP COMPLIANCE
We certify herewith
that the company Microbact AG, Gaswerkstrasse 66a, 4900 Langenthaln Switzerland, has
been duly authorized to manufacture medicinal products, the manufacturing licence including
following activities:
-
Quality control (microbiological) of medicinal products as contract laboratory excluding
tests of
sterility
:
that the company is keeping the required level for good practices in the manufactuie of:
pharmaceutical products and active pharmaceutical ingredients according to the Srniiss
regulations in force. These regulations are in accordance with the requirements for good
practices in the manufacture and quality control of the Pharmaceutical lnspection Convention
/Co-operation Scheme (PIC/S) and the Directives of the European
Commission;
:
that the manufacturing plant of the company is subject to official periodic inspections; the last
inspection was conducted on January 7,2O14;
that the requirements regarding manufacture and quality control for pharmaceutical products
and active pharmaceutical ingredients for export are identical to those applicable to products
'
sold in Switzerland.
Berne, April29,2O14
No. 14-878
Schweizerisches Heilmittelinstitut
lnstitut suisse des produits th6rapeutiques
lstituto svizzero per gli agenti terapeutici
Swiss Agency for Therapeutic Products
l-303.44.01-410e / YO2 I bia I gmel smi /30.05.1
1
Swissmedic lHallerstrasse 7 | Postfach ICH-3000 Bern 9lwww.swissmedic.ch lTel. +41 31 32202 11 lFax+41 31 32202 12

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