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CONTRACT
MANUFACTURING

Stemmatters provides contract research, development and manufacturing services of biological and cell based products under the irisbiosciences brand.

REGULATORY
COMPLIANCE

Stemmatters follows the requirements of EN ISO 9001 – Quality Management Systems and NP 4457 Research, Development and Innovation (RDI) Management Systems.

Our premises include clean rooms certified for manufacturing of human investigational medicinal products. The authorization number F059/001/2017, issued by the Portuguese Authority of Medicines and Health Products (Infarmed) in accordance with Art. 13 of Directive 2001/20/EC, confirms our compliance with the principles and guidelines of Good Manufacturing Practice laid down in Directive 2003/94/EC.

All critical processes are validated and all critical equipment and utilities are qualified as described in our Validation Master Plan. Stemmatters Quality System is in conformity with the European Good Manufacturing Practice (GMP) and ICH Q7 guidelines.

INFRASTRUCTURE

The company operates Biosafety Level-2 (BSL-2), Research and Development (R&D)and Quality Control (QC) laboratories for development of medical devices and biological products.

Our clean room facility comprises qualified controlled environment rooms (CERs), or clean rooms, and material pass throughs. CERs consist of 8 cGMP cleanroom areas.
CERs are designed to maximize environmental quality, allow manufacturing of sterile products and are compliant with requirements of the European Union Tissue and Cells Directives (EUTCD) and the guidelines for cGMP.