RegOpsPro™

Responsible Person for Import (RP-I) Operating Model™

A practical governance model for the RPi assurance function and its interfaces with the wider WDA(H) GDP quality system.

Open RP-I Execution Workspace™Open RP-I Guide™

Import oversightReceipt verificationDiscrepancy escalationTraceability

Regulatory scope. MHRA uses the term Responsible Person (import) (RPi). The statutory RPi assurance function applies to a Great Britain WDA(H) importing QP-certified human medicines from a country on the Approved Country for Import list. It confirms required QP certification and, where applicable, independent batch-release certification for biological products. Medicines sourced from Northern Ireland into Great Britain do not require RPi oversight. Wider supplier, transport, receipt, traceability and recall controls sit within the WDA(H) GDP quality system and may involve the RP, RPi, Quality and operations.

Understand the model→Use the full workspace→Use the guide→Build import outputs→Prepare governance pack

The RP-I execution standard

Use the operating model to create a defensible assurance trail for imported product. The statutory RPi assurance decision should remain distinct while the surrounding GDP evidence, discrepancies, actions and governance interfaces remain connected.

1. Import requirement

Define the product, route, import context and RPi assurance requirement before relying on the imported stock.

2. Assurance evidence

Identify the QP certification and other applicable batch-release evidence, together with the supporting import records needed by the WDA(H) quality system.

3. Discrepancy & decision

Record missing or conflicting evidence, escalation, quarantine/interface actions and the authorised RPi assurance outcome.

4. Governance & traceability

Retain the assurance trail, trend recurring discrepancies and make significant import-control weaknesses visible through governance and inspection evidence.

Use the guide for judgement.
The Practical guide explains the practical implementation path and what good RP-I oversight should look like.

Use the workspace for execution.
Open the complete workspace to move from accountability and scope into evidence, actions and governance outputs.

Put the operating model into practice

Use the complete workspace, supporting guide and linked tools to structure implementation and evidence.

Open RP-I Execution Workspace™Open RP-I Guide™View Toolkits