SOP-006 / SOP v2.0
Equipment, calibration and maintenance
Balances, thermometers, pH meters, mixers and volumetric equipment.
Procedure
- Assign a unique ID and file to each critical instrument. Define use, operating range, accuracy and acceptance criteria.
- Confirm suitability for batch size and materials. Balance readability does not mean every small weight is reliable.
- Schedule calibration and maintenance using risk and manufacturer instructions. Retain certificates and reference-standard traceability.
- Perform defined pre-use checks: balance zero/stability, appropriate pH buffers and sensor checks. Record actual values.
- For mixers record the tool, vessel geometry, load, time and speed. The same speed setting does not ensure equivalent mixing in another system.
- Label failed equipment out of service and assess batches since the last acceptable check. Return it only after documented restoration.
Edition-specific detail
Before using a balance document checks with suitable reference weights and confirm its qualified minimum weight. For pH use suitable certified buffers and record temperature and slope/offset according to the instrument manual. A failed check requires removing the instrument from use and assessing batches since its last acceptable check.
Stop criterion
Overdue critical calibration or failed check: suspend work.
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