Manufacturing and Production

Pharmaceutical Manufacturing Operations and Solid Dosage Forms

A tablet has to contain the same dose as every other tablet in the batch, disintegrate predictably and still do so two years later, and each of those is decided by unit operations that look routine on a production floor. This course works through them. Delegates work through excipient function and why a formulation is a set of deliberate choices rather than a recipe. Dispensing and material control follow. Granulation is covered across wet, dry and direct compression routes, with the endpoint determination that decides granule quality. Drying and loss on drying are addressed. Blending and the segregation that undoes it are covered, since content uniformity failures usually start there. Compression follows: tooling, weight, hardness, friability and the in process controls that catch a drifting machine. Coating is addressed. Capsule filling is covered. In process control, sampling and batch documentation follow. The course closes on yield reconciliation and on investigating an out of specification batch.