SOP-003 · Training, hygiene and clothing

SOP-003 · 1.0 · 10.09.2026

Scope

Staff, visitors and contractors entering the compounding area.

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. Define permitted tasks for each role. Initial training covers SOPs, calculations, records, cleaning and incident response.

2. Assess competency through observation and documented practice work. Reassess after significant changes or errors.

3. Perform hand hygiene before entry, after contamination and when changing activities. Exclude food, drinks and personal items.

4. Wear clean laboratory clothing and hair covering. Select gloves and eye/respiratory protection from SDS and task risk assessment.

5. Change gloves and contaminated clothing between incompatible tasks. Gloves do not replace hand hygiene.

6. Report health conditions or sensitisation affecting safe work confidentially to the designated responsible person. Assign suitable alternative tasks.

Stop criterion

Related records

• F-001 · Local adoption and risk assessment

Sources

• AEMPS PN/L/PG/002/00 — Indumentaria
• NAPRA — Model Standards for Pharmacy Compounding of Non-sterile Preparations (2018; clarification 2022)

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: __________