SOP-016 · External testing, data and change control

SOP-016 · 1.0 · 10.09.2026

Scope

Analytical partners, digital records and quality-system changes.

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. Agree in writing with the external laboratory on matrix, analyte, range, method, criteria, turnaround and deviation reporting.

2. Check technical competence and, where relevant, accreditation scope. A general certificate does not establish suitability for every test.

3. Maintain sample identity, conditions and receipt records. Link reports to the batch, method and raw data where needed.

4. Restrict records by role. Keep change history, secure backups and restoration checks; do not upload patient details to the public website.

5. Before material, method, source or equipment changes assess effects on strength, stability, exposure and previous batches. Define required comparisons.

6. Approve changes only after testing, document updates and training. Monitor initial batches after implementation.

Stop criterion

Related records

• F-001 · Local adoption and risk assessment
• F-005 · Sampling and QC results
• F-007 · Deviation, CAPA and recall

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: __________