August 8, 2022
You've likely heard the phrase “time is money.” No other statement could be more accurate for the medical device industry. Each day your company is not approved to market your device is not only a day of lost revenue, but a day patients don’t get to benefit from the value […]
August 3, 2022
CMC information reinforces the connection between the quality of a candidate drug used in clinical studies and the end product marketed to consumers. It effectively outlines critical quality attributes across the full life cycle of drug products, from clinical development to commercial scale production. Like current good manufacturing practices (cGMP, or GMP), CMC reviews have regulatory requirements established by the US FDA. But where the goals of these two pharmaceutical control strategies are closely aligned, they differ significantly in approach and regulation.
June 7, 2022
Medical devices have been saving lives for decades. And medical devices are quickly changing as new technology such as 3D printing, software, hardware and algorithms are being incorporated into device designs. Medical devices are not simply band aids and thermometers any longer. They are sophisticated designs that help people with a myriad of problems and in many cases, they prolong and save lives.
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.
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.
May 18, 2022
A robust Quality Management System (QMS) is an important aspect of a Pharmaceutical company as it demonstrates a company’s Senior Management commitment to Quality. QMS instills the mindset that assures that the company will have qualified and trained individuals who focus on “Quality” throughout the lifecycle of the product.