The Gushu facility in Shenzhen, China, achieved the accreditation after meeting the rigorous audit requirements set by MedAccred subscribing members, including Baxter, BD, Boston Scientific, Edwards Lifesciences, Johnson & Johnson, Medtronic, Philips, Roche Diagnostics and Stryker.
Jordi labs and its team of Ph.D. analytical chemists developed a proprietary, multi-detector approach to ensure that all extractables are accurately characterized to comply with global materials testing regulatory requirements.
The pandemic put unprecedented pressure on drug and medical device production, underlining the growing challenge of monitoring, analyzing, reporting and acting on quality. It became clearer than ever before that the more fragmented processes become, the more critical it is that they can be assessed and managed for consistent quality. At the same time, innovative tools and best practices have emerged.
The industry struggles with various unknowns that impact efficiency, quality, and as a result, finances. This article reviews some of these challenges and how to overcome them.
As the pace of innovation further accelerates in 2021, and the need to get new devices to market intensifies, maintaining adherence to regulatory controls is not enough.
The key is to keep quality high and risk low.
It’s time to take stock on what temporary measures need to be made permanent to grow as an industry.
Companies within the life sciences industry should rethink how they manage their data and documents.
Understanding the GMP requirements of each component is critical to product and compliance success.
It’s time to consider CAPAs as opportunities rather than just other issues to tackle.