SOP-009 · Oral solutions, syrups and suspensions

SOP-009 · 1.0 · 10.09.2026

Scope

Non-sterile oral liquids under a specifically approved master record.

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. Check solubility or the need for suspension, patient suitability of excipients and the exact active-substance form.

2. Verify water and vehicle quality. Sugar or preservative presence alone does not establish microbiological stability.

3. Follow the specific dissolution, wetting and dispersion sequence. Record temperature, time and mixing; do not transfer settings from another product.

4. Clarify whether the source requires final mass, final volume or addition of a specified vehicle. Check temperature before final volumetric adjustment where relevant.

5. Apply suitable appearance, pH, yield, redispersibility and uniformity checks. Observations do not replace required quantitative analysis.

6. Check container and dosing-device compatibility. Shaking instructions must reflect demonstrated redispersibility and be understandable to the user.

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/004/00 — Jarabes
• AEMPS PN/L/FF/007/00 — Soluciones
• 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: __________