What is an RP? A Complete Guide for UK Pharmaceutical Businesses
If you hold or are applying for a Wholesale Dealer’s Authorisation [WDA(H)] in the UK, you must name a Responsible Person (RP). This isn’t a tick-box formality. Your RP is continuously contactable, a resident in the UK, and personally accountable for day-to-day GDP compliance. In practice, the RP is the guardrail that keeps distribution quality real: training that lands, supplier and customer approval that screens risk, maintains records that stand up in MHRA inspections, all handled with evidence and pace.
What an RP is? And why it matters
By definition, the RP is the named individual on your WDA(H) responsible for safeguarding product quality and integrity throughout Good Distribution Practice operations. UK guidance expects the RP to fulfil their responsibilities personally, with the independence and access needed to intervene. That means the RP can ask hard questions, request records, halt activity where standards are not met, and escalate to senior management without theatre. When inspectors assess your operation, they assess the RP’s suitability too, competence, authority, and effectiveness are all in scope.
When you need an RP
If you procure, hold, supply, or export human medicines under a WDA(H), you need at least one RP in place. The expectation is simple: your quality system must work in the real world. Inspectors will follow the evidence trail around your GDP activities and, if the RP proves unsuitable, the licensing authority can vary your licence or take other regulatory action. In other words, the title only matters if the role has teeth.
What the RP does day to day
The easiest way to understand the RP’s scope is to picture the moving parts of GDP and imagine one accountable owner keeping the system coherent. The RP ensures a functioning quality management system (QMS); oversees authorised activities and the accuracy of records; confirms that initial and ongoing training is both delivered and effective; and coordinates complaints, returns, and recalls with clear dispositions. They control supplier and customer qualification and any outsourced activities, verify that self-inspections are happening with CAPAs that close, and make documented decisions on returned, rejected, or falsified products. For this to work, the licence holder must give the RP clear reporting lines, time on site appropriate to scope, and access to people, premises, and systems.
Who can be an RP?
A pharmacy degree is helpful but not mandatory. What matters is competence and experience. Practical exposure to the activities on your licence, knowledge and training in GDP, and a track record of maintaining a suitable QMS. Industry frameworks such as the UK Responsible Person Gold Standard can help structure training and ongoing development, but inspectors will ultimately judge effectiveness through outcomes and evidence, not job titles.
RP vs RPi vs QP. Clearing up the confusion
Three roles often get conflated. The RP (GDP) oversees distribution quality and compliance under a WDA(H). The Responsible Person (Import), RPi, is required when importing licensed medicines into Great Britain from an approved country for import; the core duty is verifying QP certification (and, for certain biologicals, batch release certificates) for each batch before entry to the GB supply chain. The Qualified Person (QP) operates under a Manufacturer’s Licence and certifies manufactured batches for release under GMP (EU/UK Annex 16). Different licences, different evidence sets, different inspection expectations. If you import and distribute, you may need both RP and RPi responsibilities covered—sometimes by the same individual, provided authority, independence, and competence are met and documented.
Can you outsource the RP?
Yes. Many organisations appoint a contract RP. If you do, name the individual (not just the consultancy) in the agreement and define scope, availability, time on site, reporting, and performance review. The licence holder remains responsible for selecting a suitable RP and enabling effective oversight. Outsourcing removes headcount, not accountability.
Getting inspection-ready with your RP
Start with the model that fits your risk: in-house RP, contract RP, or a hybrid. Align the reporting line so the RP can escalate without barrier. When you apply or vary your WDA(H) via the MHRA Portal, expect inspection focus to track your activities and history. Before inspection, line up the evidence that proves the system works: current training records and a clear job description for the RP; temperature mapping and transport validation; qualified supplier/customer lists; a self-inspection schedule with CAPA that closes on time; and management reviews that drive actions rather than minutes for show. Inspectors use a risk-based approach: your scope, outsourced activities, cold-chain exposure, and deficiency history will shape the depth and frequency of GDP inspections.
Where GDP findings usually hide and how a proactive RP prevents them
Year after year, deficiency data point to the same pressure points: documentation and records that don’t reflect reality; premises, equipment, and temperature control that look good on paper but fail under stress; operations that drift from SOPs; and QMS loops that never quite close. A proactive RP shortens the distance between problem and fix. That means walking real use-cases end-to-end, trending deviations and complaints, rehearsing recall pathways, tightening supplier oversight, and giving deputies genuine readiness, not just a name on a form.
How TDP can help
TDP supports businesses across the RP lifecycle. We run GDP gap assessments aligned to your WDA(H) scope, build the evidence pack that lets an inspector follow your logic, write procedures for use (not for show), and deliver short, scenario-based training so teams know what to do every day, not just on audit day. We also provide outsourced RP/RPi services, help with WDA(H) applications/variations, and get teams inspection-ready with mock audits, recall drills, and CAPA coaching.
Book a discovery call and let TDP’s expert guidance answer your RP questions.
Helpful Links
MHRA Inspectorate – The Responsible Person named on the WDA (Part 1): Raising the profile of the RP: https://mhrainspectorate.blog.gov.uk/2018/06/15/the-repsonsible-person-named-on-the-wda-part-1-raising-the-profile-of-the-rp/
MHRA Inspectorate – The Responsible Person named on the WDA (Part 2): Effective appointment and training: https://mhrainspectorate.blog.gov.uk/2018/07/13/the-responsible-person-named-on-the-wda-part-2-effective-appointment-and-training/
MHRA Inspectorate – The Responsible Person named on the WDA (Part 3): Expectations for the engagement of consultants as contract RPs: https://mhrainspectorate.blog.gov.uk/2018/08/08/the-responsible-person-named-on-the-wda-part-3-expectations-for-the-engagement-of-consultants-as-contract-rps/
GOV.UK – Acting as a Responsible Person (import): https://www.gov.uk/guidance/acting-as-a-responsible-person-import
EUR-Lex – Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=oj:JOC_2013_343_R_0001_01
Official Journal PDF – GDP Guidelines 2013/C 343/01 (PDF): https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2013:343:0001:0014:EN:PDF
MHRA – GDP Inspection Deficiency Data for 2016: https://mhrainspectorate.blog.gov.uk/2017/12/13/gdp-inspection-deficiency-data-for-2016/
MHRA – GDP Symposium 2023 (deficiency trends Oct 2021–Nov 2022): https://mhrainspectorate.blog.gov.uk/2023/05/02/mhra-good-distribution-practice-symposium-2023/
GOV.UK – Sourcing medicines for the Great Britain market from an approved country for import or Northern Ireland: https://www.gov.uk/guidance/sourcing-medicines-for-the-great-britain-market-from-an-approved-country-for-import-or-northern-ireland
MHRA Guidance Note 6 – Notes for applicants and holders of a Wholesale Dealer’s Authorisation [PDF]: https://assets.publishing.service.gov.uk/media/67ea784e0678ace40a7f275c/GN_6_Brexit_changes-GDP.pdf
