SOP-014 · Stability and BUD justification

SOP-014 · 1.0 · 10.09.2026

Scope

Assigning a use period for the exact formula, packaging and conditions.

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. Compare the studied and local preparations: active, salt, strength, excipients, water, pH, process and container.

2. Assess study quality and whether analysis distinguishes degradation. Preserved appearance alone does not demonstrate chemical stability.

3. Assess chemical, physical and microbiological stability separately, preservative effectiveness where required, and in-use behaviour.

4. Consider current jurisdictional requirements and material limitations. Do not automatically transfer a numerical BUD between sources or countries.

5. In F-006 record the selected period, starting point, temperature, packaging, evidence and limitations. Calculate the actual date for each batch.

6. Reassess after vehicle, supplier, process or container changes and temperature excursions. Do not extend expiry by relabelling without evidence.

Stop criterion

Related records

• F-006 · Stability and BUD rationale

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: __________