The new EU draft guidance, Guideline on the quality requirements for drug-device combinations, and U.S. draft guidance, Principles of Premarket Pathways for Combination Products, are the latest attempts by each body to adequately regulate combination products. In this two-part series, we examine the two guidances in detail. Part 1 covers the U.S. regulatory guidance.
RONCHI MARIO developed its new filler around Endress+Hauser's new Dosimag and Dosimass flowmeters. The new filling machine generation of RONCHI MARIO S.p.A. features major innovations. Endress+Hauser's Dosimag and Dosimass flowmeters with integrated batching functionality are key components of the new machine concept.
Thanks to the set-up of a result-based calibration contract with Endress+Hauser and to the simplification of the operation, this major biotechnology plant has significantly reduced overall effort and calibration costs. The calibration time has also decreased, with positive impact on the plant process’s availability rate.
A biotechnology plant was struggling with the management of the calibration of the more than 100 reference standards covered about 20 calibration service providers. Endress+Hauser took the responsibility to manage the whole calibration process of the reference standards resulting in a reduction of non-conformities achieved has led to better operational quality.
To keep the risks in bioproduction as low as possible, an increase in calibration frequency is required. Read how the self-calibrating iTHERM TrustSens temperature sensor kept downtime to a minimum.
Recent developments eliminate the need for unnecessary calibrations and speed up the time it takes to do calibrations in the field.
Read how Resin specifications, process qualification and process controls established at all stages of the manufacturing process can ensure quality, change control and business continuity.