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 or, more specific, in a hospital pharmacy’s daily routine.
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.
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.
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.