Klivon Scientific is not yet accredited under ISO 17034; nevertheless, all our processes, facilities, working methods, and organizational practices are in full compliance with ICH (International Conference on Harmonisation) guidelines, in particular Q3A (Impurities in New Drug Substances), Q3B (Impurities in New Drug Products), and Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients).
Our quality system is based on international Good Manufacturing Practices (GMP) and ISO principles to ensure traceability, reliability, and scientific robustness across all our reference standards. The company is currently progressing towards ISO 17034 accreditation as part of its continuous improvement and global compliance strategy.
It is also important to note that this accreditation (ISO 17034) is not “global” for the company, but rather assigned on a molecule-specific basis.
The certificate is issued by scope, meaning it applies to the molecules (or classes of molecules) listed in the technical annex of the accreditation. The accreditation body evaluates whether the characterization methods, equipment, metrological traceability, and quality controls are appropriate for those specific substances.
Therefore, the accreditation applies directly only to the Certified Reference Materials (CRMs) within the approved scope.
All our processes, facilities, working methods, and organizational practices are in full compliance with ICH (International Conference on Harmonization) guidelines, in particular Q3A (Impurities in New Drug Substances), Q3B (Impurities in New Drug Products), and Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients).
Our quality system is based on international Good Manufacturing Practices (GMP) and ISO principles to ensure traceability, reliability, and scientific robustness across all our reference standards.
