Plain definitions for anything above, so nothing here depends on knowing our system.
Master formulaThe approved recipe and method for a product. The batch record is meant to be its filled-in copy for one specific batch.
Batch recordThe document an operator fills in while making a batch — every weight, time, temperature and signature as it happens.
DispensingWeighing out each raw material before manufacturing starts.
Line clearanceThe documented check that the room and the equipment are clean and empty of the previous product before a new batch begins.
DeviationAnything that departed from the approved instructions. Each one is expected to be recorded and explained at the time.
YieldHow much product actually came out, as a percentage of how much should have.
ReconciliationProving the weights add up — what went in, what came out, and what was lost along the way.
Active ingredientThe component that does the medical work. Here, Clotrimazole — 1% or 2% of the batch depending on the product.