SOP-015 · Deviations, CAPA, complaints and recall

SOP-015 · 1.0 · 10.09.2026

Scope

Errors, near misses and problems identified after supply.

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. Immediately protect patients and staff: stop work, isolate materials and alert the responsible person. Urgent clinical care comes before paperwork.

2. Record time, product, lots, facts and available evidence without deleting original data. Separate facts from assumptions.

3. Assess scope and other batches sharing the material, equipment or process. Quarantine potentially affected items.

4. The responsible person determines communication with prescribers, recipients and authorities under applicable obligations. Maintain recall records and quantity reconciliation.

5. Analyse root cause and assign corrective/preventive actions, owners and deadlines. Retraining alone is insufficient when the system causes the error.

6. Verify CAPA effectiveness and document closure. Periodically exercise a mock recall to demonstrate traceability.

Stop criterion

Related records

• F-007 · Deviation, CAPA and recall
• 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: __________