SOP-001 · Document control and local adoption

SOP-001 · 1.0 · 10.09.2026

Scope

Every SOP, monograph, master record and form used in the laboratory.

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. The responsible pharmacist assigns a document owner, author and independent reviewer. Downloading from this site is not local approval.

2. Record the identifier, version, source, access date and applicable requirements. Check references, units and unresolved monograph issues.

3. Complete F-001 with the local implementation: facility, equipment, responsibilities, tests and acceptance limits. Justify every departure from the template.

4. Approve with signatures and an effective date before use. Train staff and document competency assessment.

5. Provide one controlled active version at the workstation. Withdraw obsolete copies while retaining historical batch records.

6. Set a review date and trigger an unscheduled review after source, material, equipment or incident changes. Assess affected batches.

Stop criterion

Related records

• F-001 · Local adoption and risk assessment
• F-002 · Master formulation record

Sources

• AEMPS PN/L/PG/001/00 — Elaboración de procedimientos
• NAPRA — Model Standards for Pharmacy Compounding of Non-sterile Preparations (2018; clarification 2022)

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: __________