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Laboratory Information Management Systems (LIMS)

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Elemental impurities testing and specification limits – ICH Q3D

22 December 2018 | By

The introduction of ICH Q3D (Guideline for Elemental Impurities)1 was an additional safety-based guidance for toxic impurities that complemented the existing ICH Q3C(R5) (Impurities: Guideline for residual solvents)2 and ICH M7(R1) (Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk);3 as well as the…

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Integrating data from QC and Production to enable fast, informed decisions

2 November 2018 | By

Managing the vast amounts of data involved in biopharmaceutical manufacturing and quality control workflows is often challenging due to the use of multiple stand-alone systems and devices that can act as information silos. However, with the need for tighter control of collected data, due to an increased regulatory focus, safeguarding…