SOP-010 · Semisolids, emulsions and gels

SOP-010 · 1.0 · 10.09.2026

Scope

Non-sterile cutaneous forms; other routes require separate suitability assessment.

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. Verify base identity, emulsion type and compatibility of active, pH and preservative. Do not assume commercial bases are interchangeable.

2. Define required comminution, wetting or dissolution. Choose compatible aids without arbitrarily adding a new excipient.

3. Follow the phase temperatures and addition sequence of the specific method. Record actual thermal history.

4. Define mixing and cooling to control heterogeneity, air entrapment or destabilisation. Equipment changes require assessment.

5. Check appearance, agglomerates, separation, yield and, where required, pH/rheology/assay using suitable methods.

6. Fill a compatible container and check net quantity and closure. Assess the effect of jar versus tube use on BUD.

Stop criterion

Related records

• F-003 · Blank batch record
• F-005 · Sampling and QC results
• F-006 · Stability and BUD rationale

Sources

• AEMPS PN/L/FF/002/00 — Emulsiones
• AEMPS PN/L/FF/006/00 — Pomadas
• 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: __________