After several years of development following its passage in 2011, the Food Safety Modernization Act (FSMA) is now in effect. As the legislation transitions the U.S. Food and Drug Administration (FDA) into a law enforcement authority, versus regulatory agency, it’s critical for shippers and couriers...Read More
Poor storage conditions that expose delicate pharmaceuticals and biologics to changes in temperature and humidity can be very costly in the form of lost product, poor end quality for patients, and damage to reputation.
What Defines Pharmaceutical Product Quality?
Pharmaceutical products must be...Read More
From a decade ago, cloud computing has come a long way – spreading to a wide array of industries. Recently, the highest amount of IT investment in life sciences industry has been on cloud computing. The cost and time commitment to develop a new drug nearly doubles every nine years. Pharma and...Read More
What is Cold Chain Management?
Many products in the pharmaceutical industry, such as modern biologics, monoclonal antibodies, vaccines, gene therapies, some types of insulin, and some cancer treatments require strict adherence to a precise temperature range at all times. This cold chain...Read More
A growing trend in the pharmaceutical industry is the development of more complex and fragile products, like biologicals, chemical mixtures, and large molecules (COVID-19 vaccines are an example of this trend).Read More
Why is Pharmacy Temperature Monitoring so Important?
If medications and vaccines are stored at the wrong temperature, several things can go wrong – rendering them less effective than intended or even chemically altered, causing inadvertent patient harm. Because of this risk, pharmacy regulations...Read More
Since their introduction, IoT devices have evolved from technical curiosities to ubiquitous elements in daily life, finding applications in home automation, healthcare, manufacturing, agriculture, traffic control, and a diverse collection of other areas.Read More
A central aspect of doing business in highly regulated industries, like pharmaceutical manufacturing and distribution, healthcare, or aerospace, is the need to have extensive systems in place to protect consumers and maintain regulatory compliance. That includes systems to monitor the environmental...Read More
Cold chains are specially designed distribution networks in which product temperature is controlled and monitored from end to end. Many types of products are distributed using cold chains, including produce, frozen foods, specialty chemicals, and the focus of this article, pharmaceuticals.Read More
The health of American citizens relies largely on the quality and authenticity of the prescription drugs they take. Even though the United States takes precautions to secure the integrity of the medication supply chain through the FDA, problems can still arise. In order to address potential risks...Read More