Responsible Person (RP) & Qualified Person (QP) Services
External assurance & governance — Professional & assurance
The contract professionals who hold two named legal roles in the EU/UK system: the Qualified Person (QP) who certifies each batch for release, and the Responsible Person (RP) who oversees a wholesale distributor’s GDP compliance. These are personal, named responsibilities — a service provider fills the role, but the legal duty attaches to the individual.
What this page does not claim
The rings are SPEQ’s map of who operates in the regulated ecosystem, not a legal or regulatory classification. Where an organization type already has a canonical page, this points at it rather than describing it twice.
QP certification is the legal gate to releasing a batch and the RP is legally accountable for GDP compliance — named roles without which product cannot lawfully reach the EU/UK market.
The regulated-relevance test — an adjacent subject belongs only when it materially affects one of ten regulated concerns.
- Provide QP batch certification and release under EU/UK GMP
- Act as the named Responsible Person for a wholesale-distribution authorisation
- Oversee GDP compliance, supplier/customer qualification, and returns/falsified-medicine controls
- Advise on importation and QP certification of third-country product
QP certification is the legal gate to market: no batch is released for sale in the EU/UK without a QP’s certification under EU GMP Annex 16, and the QP must be satisfied the batch complies — a personal, non-delegable judgement.
The Responsible Person is personally accountable for a distributor’s GDP compliance under the EU GDP guidelines; the role cannot be reduced to a name on a licence who never exercises it.
Because these are named individual duties, a service arrangement must give the RP/QP genuine authority and access — an RP or QP who cannot actually oversee or refuse is a compliance fiction.
- A named RP/QP who lacks real authority, time, or access to discharge the role
- QP certification treated as a rubber stamp rather than a personal compliance judgement
- Gaps at the importation/QP-certification interface for third-country product
The 4 standards SPEQ maps to this org type’s quality interface, across 3 regulatory bodies: ICH, EC, EMA.
FREQUENTLY ASKED
What is the difference between a QP and an RP?
A Qualified Person (QP) certifies each batch of a medicinal product for release under EU/UK GMP — the legal gate to market, governed by EU GMP Annex 16. A Responsible Person (RP) oversees a wholesale distributor’s Good Distribution Practice compliance under the EU GDP guidelines. Both are named, personal legal roles; one sits at manufacture/release, the other at distribution.
Can the QP or RP role really be outsourced?
The person can be a contractor, but the legal responsibility attaches to the named individual, not the company that supplies them — and it cannot be reduced to a name on a licence. A contract QP or RP must have genuine authority, time, and access to discharge the role, including the ability to refuse. An RP or QP who cannot actually oversee is a compliance fiction an inspector will see through.