51ÁÔÆæ

Everything you do in pharma manufacturing catches up to you eventually. And just like the state of your complexion, pharmaceutical equipment loses its pep over time and cracks around the...

Q. I have just been promoted to be in charge of investigations for my company. Our standard operating procedure (SOP) requires us to complete an FDA investigation in 30 days....

Q. What is a deviation & do all deviations need a root cause analysis? A. A deviation is when there is a failure to follow the instructions guiding the performance...

What is a CDMO? A CDMO is a Contract Development and Manufacturing Organization. These are companies in the pharmaceutical, biotechnology, and medical device industries that provide outsourced services to other...

The amount of quality assurance detail included in Standard Operating Procedures (SOP) may help a company stay QA compliant, says Susan J. Schniepp, Distinguished Fellow at 51ÁÔÆæ, Inc....

Q: I am a regulatory professional working for a small company with a product in the early stages of development. Can you tell me when I need to submit the...