ALL ABOUT LOTS, TOXIC OR OTHERWISE

There's lots on lots that you don't know about

WHAT DO THE REGULATIONS SAY ABOUT LOTS?

The FDA cGMP definitions can be found here. Below is a definition of a lot (batch) and lot number

Lot means a batch, or a specific identified portion of a batch, having uniform character and quality within specified limits.

Lot number, control number, or batch number means any distinctive combination of letters, numbers, or symbols, or any combination of them, from which the complete history of the manufacture, processing, packing, holding, and distribution of a batch or lot of drug product or other material can be determined.

IT’S NOT LIKE BAKING CAKES

Comparisons with baking cakes are simplistic in the extreme when compared with injections, but here it may be helpful.

Say you are baking cakes. You insert the ingredients, mix them a food mixer, and tip the contents onto a baking tray. What came out of the mixer is a batch, or lot.

It is the same with active pharmaceutical ingredients (APIs). The difference is a bad batch of cakes is disappointing, but…