Quality Assurance

GMP compliance

GlycoThera maintains a quality system in full compliance with the EC Guide of Good Manufacturing Practice (GMP) for medicinal products and ICH guidelines. The quality system comprises all required measures to ensure full control and traceability of operations and results. Analyses are carried out through well-trained personnel applying validated analytical procedures using qualified and calibrated instruments and equipment.

Based on thorough review of the results and related documentation, Certificates of Analysis (CoA) are issued by GlycoThera's quality assurance (QA) unit.
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