SOP-005 · Facility, cleaning and line clearance

SOP-005 · 1.0 · 10.09.2026

Scope

Non-sterile compounding area and shared 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. Define receiving, quarantine, clean-material, compounding and finished-product zones. Arrange workflow to limit mix-ups and cross-contamination.

2. Before each job remove materials, labels and documents from the previous batch. Record line-clearance verification.

3. Use an approved cleaning procedure for each surface and residue. Define agent, concentration, contact time and rinsing from suitability evidence.

4. Record scheduled and exceptional cleaning, operator, materials and outcome checks. Disinfection does not replace removal of chemical residues.

5. For potent substances or allergens use specific residue controls and demonstrated cleaning suitability. Visual cleanliness is insufficient.

6. Monitor temperature, humidity or other conditions where product quality depends on them. Record excursions and risk-appropriate waste management.

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/PG/002/00 — Indumentaria

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: __________