Stasinos Chr. Sikalias · The science of compounding

Batch worksheet: Firm hydrophilic cream 2 EX004

CGR-ES-042 · Blank fields for controlled execution

For local reviewCGR-ES-042Spain · AEMPS

WORKSHEET FOR LOCAL APPROVAL — source authority does not replace batch approval.

Companion batch worksheet. Use with the full monograph and a locally approved master record. This is not a standalone recipe. Complete by hand after printing.

Full monograph PDF

CGR-ES-042 · Monograph 4.0 · Web 4.0 · 10.09.2026

Local master ID / versionBatch / date

Materials and actual quantities

MaterialSourceLocal targetActual amountLot / expiry / check
Emulsifying cetostearyl alcohol Type B18 g
White soft paraffin15 g
Liquid paraffin10 g
Propylene glycol12 g
Sodium lauryl sulfate1 g
Preserved water AEMPS EX001q.s. ad 100 g

Local batch size, units, calculations and independent check

Line clearance, equipment, calibration and cleaning

Stages, times, actual parameters and observations

Yield, losses and reconciliation

QC: samples, methods, limits and actual results

Deviations, investigation and decision

Packaging, label, storage and actual BUD justification

Operator, reviewer and releasing pharmacist — signatures / dates