SOP-004 · Suppliers, receipt and raw materials

SOP-004 · 1.0 · 10.09.2026

Scope

Active substances, excipients, commercial products and packaging materials.

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. Qualify suppliers for identity, quality, traceability and recall capability. Define an appropriate pharmacopoeial or other justified specification.

2. At receipt check the name, salt/hydrate form, lot, integrity, quantity, expiry and transport conditions.

3. Match the CoA and SDS to the exact lot/material. Assess identity, assay and critical impurities; the document title alone is insufficient.

4. Quarantine until the required review is complete. Record acceptance or rejection by an authorised person.

5. Label opening date, conditions and any justified in-use period. Segregate allergens and incompatible materials.

6. Maintain inventory and lot movements using earliest-expiry priority. Every substitution or supplier change enters change control.

Stop criterion

Related records

• F-001 · Local adoption and risk assessment
• F-008 · Allergen raw-material dossier

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: __________