Understand which products need child resistant packaging how can manufacturers ensure they are up to standards.
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.
Clinical supply models need to provide for an adequate supply of patient kits that allow for variations in patient recruitment levels and clinical site activity. Traditional, or supply-led models, address this challenge by creating large quantities of finished patient kits upfront in order to create a cushion of static inventory to manage uneven demand. However, this cushion comes at a cost including lingering potential for stock-outs at high recruiting or new clinical sites, 30-200% drug waste and weeks or even months of lead time for packaging.
Widespread and diverse, the Asia-Pacific (APAC) region spans over two dozen countries where a population of over two billion and growing conduct business in more than a dozen major languages including Mandarin Chinese, English, French, Dutch, Korean, Japanese, Filipino, Vietnamese, Thai, Malay, and Khmer.
Explore how to drive excellence within the forecasting process and how to utilize forecasting throughout the study to plan for study clinical supply budgets and identify potential supply-related issues before they negatively impact your study.
As certain regions of the world are added to a clinical study, the logistical and regulatory challenges associated with clinical trial supply distribution can rise exponentially. Underestimating the often complex distribution logistics necessitated by the sensitive and highly regulated nature of clinical supplies can potentially put a study’s budget and timeline—and more importantly, patients— at risk. Standards and accepted practices in one part of the world may be unacceptable in another.