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.
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.
Recruiting patients and retaining their participation in a clinical trial remain the biggest challenges faced by pharmaceutical companies when developing new medicines. For a patient, participation in a clinical trial can be stressful and burdensome, resulting in one in four patients dropping out of a clinical trial prior to completion. With sponsors facing tight-timelines, increased regulatory scrutiny and spiralling budgets the desire to address these challenges has never been more prominent.
Batch processes are common in pharmaceutical, biopharmaceutical, food, beverage and chemical industries. When building models across various batches one may often encounter varying batch lengths and the batches may start from various relative points of time in a chemical context. Batch Modeling is important for process development and understanding the process for batch similarity and why some batches give a product quality outside the specifications.