March 2, 2022
Beginning with spring training through the dog days of summer to the stretch drive, every decision on and off the field can affect the postseason outcome.
March 23, 2022
Before the stage is set and the curtain rises for a debut performance, the time-consuming process of putting together a Broadway show is the perfect analogy used by Jim Mencel, Senior Drug Substance Consultant at Design Space InPharmatics, to describe process validation for Active Pharmaceutical Ingredients (APIs) when preparing for filing with the FDA.
April 6, 2022
The FDA has been investigating the presence of nitrosamine impurities in certain drug products. Since 2018, several drug products including ARBs, ranitidine, nizatidine, and metformin have been found to contain unacceptable levels of nitrosamines. Nitrosamines are classified as probable human carcinogens based on animal studies and there has been a pressing need to remove the risk to patients.
April 20, 2022
In the era of the coronavirus pandemic, all aspects of life were shown to have had the rug pulled out from underneath them. Each facet of our working and personal lives has gone remote. This virus put an end to travel and in-person work processes. Looking at pharmaceutical companies, there was a need to adopt virtual options to complete critical processes by the corporations and outsiders’ involvement.
June 1, 2022
Audits are necessary. However, just as we learned during the COVID-19 pandemic, that many people could perform their jobs perfectly well without getting in their car or on a train to come to the office, we have also seen that many audits can be done well…virtually. There is a place for both virtual and on-site audits.
June 1, 2022
Episode 25 of CMCLive delved into the PDA- the Parenteral Drug Association, going in-depth as to what this association is with microbiology expert Mike Carroll. Carroll, having over 30 years in the pharmaceutical field under his belt leads to a wealth of knowledge about the field of microbiology.