Follow every intermediate, campaign batch and impurity result of an active ingredient.

An API plant makes a molecule in stages. Starting materials become intermediates, intermediates become crude product, and crude product is purified, dried, milled and packed. At every stage a sample is tested, and a stage that fails its specification can send material back for rework, reprocessing or rejection, each of which must be written down. Every step leaves a record.

This software keeps the chain of stages in one place. Each lot of final product shows the intermediates behind it, the reactors and solvents used, the test results and any deviation raised on the way. Your quality unit decides how review and release work. The software records them. It does not replace them.

Chemists and operators work in campaigns, running the same product through the same reactors, centrifuges and dryers for several weeks before the plant changes over to something else. Cleaning follows. A batch begins when starting materials and solvents are charged to a reactor. Temperature, pressure and hold times are logged. At the end of the stage the mass is filtered or centrifuged, washed, and dried in a tray or vacuum dryer, and a sample goes to the laboratory.

The laboratory runs assay, related substances, residual solvents, water content and particle size. Deviations are raised when something goes outside the written process, and each one needs investigation and a decision on impact before the lot is allowed to move on to the next stage. Purified product is milled and blended, packed in lined drums with a seal number, and shipped with a certificate of analysis. Change control governs any alteration to the route.