Yield and reconciliation

Yield (%) = (actual yield ÷ theoretical yield) × 100

Reconciliation: material in = blend out + samples + waste + retained losses

Compare yield with the limits in the BMR. Typical causes of low yield are losses during dispensing, sieving, blending or discharge, powder retained in equipment, dust extraction losses, spillage, recording errors and quality rejects (see C-06).

Auditors typically review BMRs, dispensing records, reconciliation reports, yield calculations, deviations, CAPA and cleaning records.