Q𝘂𝗮𝗹𝗶𝘁𝘆 𝗵𝗼𝗿𝗿𝗼𝗿 𝘀𝘁𝗼𝗿𝗶𝗲𝘀

𝗛𝗮𝗹𝗹𝗼𝘄𝗲𝗲𝗻 𝗶𝘀 𝗷𝘂𝘀𝘁 𝗮𝗿𝗼𝘂𝗻𝗱 𝘁𝗵𝗲 𝗰𝗼𝗿𝗻𝗲𝗿, 𝘀𝗼 𝗜 𝘁𝗵𝗼𝘂𝗴𝗵𝘁 𝗶𝘁 𝗺𝗶𝗴𝗵𝘁 𝗯𝗲 𝗳𝘂𝗻 𝘁𝗼 𝗿𝗲𝗺𝗶𝗻𝗶𝘀𝗰𝗲(?) 𝗮𝗯𝗼𝘂𝘁 𝘀𝗼𝗺𝗲 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 𝗵𝗼𝗿𝗿𝗼𝗿 𝘀𝘁𝗼𝗿𝗶𝗲𝘀 - 𝗱𝗼 𝘆𝗼𝘂 𝗵𝗮𝘃𝗲 𝗮𝗻𝘆 𝘁𝗼 𝘀𝗵𝗮𝗿𝗲?

Here's one for today... One of my team was involved in developing a new drug form, and small-scale batches had been manufactured, getting ready for full stability/exhibit batches and then drug registration.

But the product kept failing its appearance test. And nobody could figure out what was going on, thinking it was an issue with manufacturing.

As the Out of Spec investigation became a full-blown deviation investigation, with the net cast wider looking for root cause, the original material was re-checked.

Turned out that the full compendial testing had not been performed! How did the material get released for use? So... the root cause of the finished product failure was failing to follow the GMP material management process.

This can be a tricky area, because the material is technically not being used for commercial manufacture, so some companies do not enforce full GMP rigor in material specs, testing,

QC release, or vendor qualification. Could this be a potential issue on your site?

We're dying to hear your quality horror stories too! 😁😆🤣 Share your experiences and insights, and let's turn these tales of dread into lessons for better quality practices.