FDA

April 2, 2021

Without temperature monitoring, the foods you buy at your local grocery store would be hotbeds for dangerous bacteria. The kind of bacteria that can lead to serious illnesses and multiple infections. Fortunately, there are food safety standards in place at every step of the production chain to minimize risks. This is true at grocery stores

January 12, 2021

Everyone who manufactures, stores, or transports pharmaceuticals must regulate temperatures. One survey looked at how often these companies experience variations. About 44.6 percent of survey participants reported many temperature changes each year.Monthly temperature changes occurred according to 16 percent of respondents. Two of every five or 41 percent of changes were more than four degrees. Another 21

September 26, 2020

Time and experience have taught most of us that monitoring the temperature helps keep our medications safe and effective. In fact, pharmaceutical temperature monitoring has become a mandatory measure that the Federal Drug Agency (FDA) and the International Council on Harmonisation (ICH) require. Both the FDA and ICH require medications to have a temperature monitoring

March 18, 2019

Did you know that an FDA inspector typically schedules a bioresearch monitoring (BIMO) audit within five days of arrival? Would your clinical have BIMO inspection readiness in such a short time? Well, it should be: these inspections can occur at any time during a clinical trial, and there is no hard rule for how much notice they have to provide. If you are

February 22, 2019

75% of laboratory errors occur in the handling and processing phase of a specimen. Human error is the main factor that creates blunders in the lab setting. Collection methods and psychological factors of the person performing the process are two examples. Staffing would be needed around the clock for settings that require temperature monitoring; this introduces the

November 2, 2018

The pharmaceutical industry has very strict guidelines to control biological products. Time, temperature, and other variables affect the safety and usefulness of these medicines. Who keeps track of these variables? Are they still using a handheld probe and a sheet of paper to keep records? How does that fit into reporting requirements? The World Health