PinnedShamik PanditAn Amble Through the PreambleAll federal agencies go through an essential bureaucratic process called Rule Making. FDA is no exception. Back in 1978, when cGMPs for…Jun 22, 2023Jun 22, 2023
PinnedShamik PanditDo you have to share Internal Quality Audit reports to FDA?The short answer is — No! But, FDA can ask you to demonstrate how you comply with your internal quality audit procedures. Specifically…Jun 15, 2023Jun 15, 2023
PinnedShamik PanditWait! You’re doing the Root Cause wrong!Since the ’80s, our brains have been drilled by the term Rootcause. It’s such a dull but pesky word that has immense sticking power in our…Jun 5, 2023Jun 5, 2023
Shamik PanditQuality Unit ResponsibilitiesIn this article we will discuss the responsibilities and authority of the Quality unit (Link: 21 CFR 211.22).Apr 23, 2023Apr 23, 2023
Shamik PanditReady for the fire inspector?When I was in my twenties, I worked for a small company in a large city. One day, my supervisor asked me to grab the tag on the ceiling…Jan 7, 2023Jan 7, 2023
Shamik PanditHosting and Managing FDA InspectionsTypes of FDA Officers who conduct inspections:Mar 24, 2022Mar 24, 2022
Shamik PanditWinter of Lockdown, Summer of DiscontentThe lockdown is easing, and we’re in a yellow zone. Pretty soon, we’ll be green. The world is waking up from this surreal experience. I…Jun 7, 2020Jun 7, 2020
Shamik PanditinGMP NotesRoot Causes of Non-ComplianceThe culture of quality and compliance has lately become a buzz phrase among my Pharma colleagues. People often list the root causes, as…May 30, 2020May 30, 2020