SOP-012 · Packaging, labelling and handover

SOP-012 · 1.0 · 10.09.2026

Scope

Every finished preparation and its safe-use instructions.

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. Approve the exact container, closure and dosing device based on compatibility and use.

2. Check cleanliness, integrity, code and packaging lot. Record fill quantity and closure.

3. Generate a label from a controlled template showing name, strength and unit basis, route, batch, preparation date, BUD and storage.

4. Add individual directions only from the confirmed prescription. Distinguish dose in mL from strength in mg/mL and specific warnings.

5. A second check reconciles the container, label and batch record. Void unused labels that could cause a mix-up.

6. At handover verify the recipient, explain storage/use with teach-back, and document required transport/cold-chain arrangements.

Stop criterion

Related records

• F-003 · Blank batch record
• F-010 · Allergen traceability and handover

Sources

• NAPRA — Model Standards for Pharmacy Compounding of Non-sterile Preparations (2018; clarification 2022)
• NAPRA — Guidance Document for Non-sterile Preparations

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: __________