Given the complexities involved and time required for assessment and decision-making activities, it is imperative to start working toward meeting the EU’s Falsified Medicines Directive (FMD) standards immediately, leveraging previous efforts for compliance with other market regulations.
Millmount Healthcare, a world-leading Health Products Regulatory Authorized Organization, specialize in pharmaceutical and healthcare blister and bottle/tub contract packaging. Millmount pride themselves on attention to detail and strict punctuality to fit stringent production requirements. Millmount found themselves in need of user-friendly, compact TQS solution capable of combining precise weighing with reliable serialisation of packaged products. The OCS Traceable Quality System represents a unique solution that combines all the future global Track & Trace requirements in one single system, intuitive and very easy to operate.
The medium-sized pharmaceuticals company Krewel Meuselbach GmbH manufactures top-quality, affordable pharmaceuticals at its Eitorf (North Rhine-Westphalia) and Gehren (Thuringia) sites in Germany, using state-of-the art technology.
The next milestone for manufacturers, November 27, 2017, is the date by which pharmaceutical manufacturers are required to print a unique product identification code on all Rx units of sale and homogenous cases distributed domestically.
The newly developed G1-3 fermentation process makes use of short, straightforward fermentation regimes for optimized space time yield.
In this webinar you will learn how to maintain data integrity in environmental monitoring applications. Participants will get an up-to-date overview of the current regulatory expectations for practices that ensure data integrity.
Watch the on-demand webinar and discover InTemp from Onset - an entirely new, fully-integrated, end-to-end temperature monitoring technology for Good Distribution Practices in the pharmaceutical supply chain.
New therapeutic products require new technologies, capabilities, resources and a thorough understanding of how temperature impacts preclinical and clinical studies and commercialization of regenerative medicines.