SOP-007 / SOP v2.0
Calculations and weighing
Batch calculations, units, potency corrections and weighing records.
Procedure
- Define the strength basis: w/w, w/v, v/v, salt or free base. Distinguish added volume from final q.s. ad.
- Check composition and mass balance against the source. Do not silently repair discrepancies or assume water-like density.
- Record the scaling factor and any assay, water or equivalence correction only with suitable data. A second person independently checks critical calculations.
- Select a balance and vessel within the qualified range. A quantity below reliable weighing capability requires an approved alternative procedure.
- Weigh one material at a time, verifying identity and lot. Record the actual quantity, unit, operator and independent check where required.
- Reconcile inputs, losses and final yield against predefined limits. Do not simply top up volume to conceal active-substance loss.
Edition-specific detail
For scaling, k = requested final quantity / reference quantity; apply the same k to every quantitative ingredient. A q.s. ad instruction means make up to the final total, not add that entire amount. The reviewer recalculates from the original order, not merely the operator’s result. Document any justified salt, hydration or potency correction separately.
Stop criterion
Unit ambiguity, unexplained yield or unchecked critical calculation: quarantine.
Related forms
Sources and references
- NAPRA — Model Standards for Pharmacy Compounding of Non-sterile PreparationsMarch 2018, clarification January 2022Sections 4–9Risk, personnel, facilities and QA; its historical BUD table is not used for current USP defaults2026-09-12
- NAPRA — Guidance Document for Pharmacy Compounding of Non-sterile PreparationsMarch 2018, clarification January 2022Sections 5, 6 and 7; master/batch records, delivery, qualityQuality-system implementation; historical BUD table not substituted for 2022 USP revision2026-09-12
- PIC/S — Guide to Good Practices for the Preparation of Medicinal Products in Healthcare EstablishmentsPE 010-4, 1 March 2014Chapters 1–9; Annex 2 (nonsterile liquids, creams, ointments)Professional quality-system framework; not automatic national legal adoption or certification2026-09-12