FOR PHARMACISTS · REFERENCE EDITION 8.0261 monographs · 32 SOPs · 18 forms

SOP-006 / SOP v2.0

Equipment, calibration and maintenance

Balances, thermometers, pH meters, mixers and volumetric equipment.

Procedure

  1. Assign a unique ID and file to each critical instrument. Define use, operating range, accuracy and acceptance criteria.
  2. Confirm suitability for batch size and materials. Balance readability does not mean every small weight is reliable.
  3. Schedule calibration and maintenance using risk and manufacturer instructions. Retain certificates and reference-standard traceability.
  4. Perform defined pre-use checks: balance zero/stability, appropriate pH buffers and sensor checks. Record actual values.
  5. For mixers record the tool, vessel geometry, load, time and speed. The same speed setting does not ensure equivalent mixing in another system.
  6. 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

F-004, F-007

Sources and references

  1. 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
  2. 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
  3. 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