A viable QMS cannot be based upon anything except data and records that are attributable, legible, contemporaneous, original, accurate, complete and easily retrievable.
Density measurement is a powerful and important method to ensure in-process control (IPC) and quality control of final products in pharmaceutical production facilities.
Anton Paar's Generation M density meters and Abbemat refractometers deliver accurate and repeatable measurement results while providing system security for 21 CFR Part 11 compliance.
With 840 million inhabitants, and two-thirds of global pharmaceutical sales, the US and Europe are also a lucrative target for drug crime. New sales channels such as the internet as well as global and more complex manufacturing and distribution channels make it increasingly easier for pharmaceutical counterfeiters to market counterfeits directly or to infiltrate the supply chain.
The reality is that paper is more of a habit than a requirement. AstraZeneca discovered this when they aimed to introduce ELNs to improve the efficiency of their validated workflows for GMP API manufacture.
In 2008 Hollister did a thorough evaluation of available solutions to automate some key internal business processes including the tracking of product registrations and the management of CAPAs. Since Hollister has to track registrations for its products in many different countries, the Regulatory Affairs department needed an automated solution to track when a registration was coming due so they could submit a new packet to renew a registration. Additionally Hollister needed to upgrade its existing Corrective Actions and Preventative Actions (CAPA) management system that was built on a Lotus Notes platform that was going to be retired.
The drug-device combination product market is growing at a rapid pace. By 2019 it is expected that the global market for drug device combination products will reach $115.1 billion. This is nearly double its worth from $66 billion back in 2012. This burgeoning market will likely bring in a flood of product submission applications to the FDA at a time when resources are already strained.
Technology, enabled by the Industrial Internet of Things (IIoT), is empowering organizations to shift to a holistic and operations-centric view where proactive and predictive maintenance (PdM) enables front line personnel in life sciences to act before costly failures occur.
From 2006 through 2015, Patheon helped clients earn 92 NDA approvals. That’s twice as many as any other CMO. Success brings more success at this stage. That’s because depth of experience, reliability of quality and refinement of processes are all important in the final push for regulatory approval and making the transition to commercial manufacturing.
In this webinar, academic and industry experts present several case studies that illustrate how novel lipid formulation strategies.
In this webinar, experts review the physiological changes of gut diseases and discuss how formulation approaches can potentially enable local delivery of macromolecule drugs orally with case studies.
In this webinar, industry experts discuss several factors that impact early phase development and clinical success to help progress development to the next phase in a timely and cost-efficient manner.
This webcast will not only reveal the current trends and challenges in Biologics manufacturing, but also new business models and how technology can drive high quality and operational efficiency.
