SOP-006 · Equipment, calibration and maintenance

SOP-006 · 1.0 · 10.09.2026

Scope

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

Roles and prerequisites

Responsible pharmacist: approves implementation and release. Trained operator: performs and records work. Reviewer: verifies critical items. Specialist clinician/analytical partner: as specified.

Before implementation complete local document IDs, named roles, suitable equipment, specific specifications and acceptance criteria. Check the applicable framework in your country.

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.

Stop criterion

Related records

• F-004 · Equipment and cleaning record
• F-007 · Deviation, CAPA and recall

Sources

• NAPRA — Guidance Document for Non-sterile Preparations
• AEMPS PN/L/OF/001/00 — Pesada

These sources inform the original editorial synthesis. Their publishers do not adopt or endorse this SOP.

Local approval

Local version: __________ Effective date: __________
Author: __________ Reviewer: __________ Pharmacist approval: __________
Signatures / dates: __________ Next review: __________