GUIDES
Reference for the
people accountable.
Practical reference material on GDP, wholesale distribution and the Responsible Person role, written for people who have to act on it. Each guide names the primary source it draws from.
What a Responsible Person is actually required to do
Every wholesale dealer’s licence names a Responsible Person. The role is defined narrowly in the GDP guidelines and more practically by what MHRA inspectors expect to see evidence of. This guide separates the two.
Licensing guideThe wholesale dealer’s licence, and what holding one commits you to
A wholesale dealer’s licence is not a one-off approval. It is a continuing commitment to operate a GDP-compliant quality system, and most of the effort sits after the licence is granted rather than before.
Operations guideHandling a temperature excursion without guessing
Temperature excursions are the most common decision an RP is asked to make at short notice, and the most common place where a decision is made without the evidence to support it. The order of operations matters.
Quality systems guideRunning a self-inspection that would survive an inspection
Chapter 8 requires self-inspections on a prearranged programme. The requirement is short; the reason it generates findings is that most programmes are either not prearranged, not independent, or not closed out.
Quality systems guideDeviations and CAPA that close properly
Most deviation systems fail in the same two places: root cause analysis that stops at the symptom, and closure without effectiveness review. Both are visible to an inspector reading the log.
Documentation guideThe SOPs a GDP wholesaler is expected to hold
GDP does not publish a list of required SOPs. It sets out activities that must be controlled by written procedures, and the list below is the set that follows from reading the chapters in order.
Inspection guidePreparing for a GDP inspection
Inspection preparation is mostly retrieval, not creation. The sites that do well are the ones that can produce evidence quickly, because slow retrieval invites the inspector to look further.
Operations guideCustomer and supplier qualification under GDP
Chapter 5 requires wholesalers to obtain supplies only from authorised persons and to supply only those entitled to receive. The failure mode is almost always the same: a check performed once at onboarding and never repeated.
Operations guideWhat to do when a medicine is suspected of being falsified
Suspected falsified product is one of the few situations where GDP expects action before investigation. Segregation and notification come first; establishing what actually happened comes second.
Operations guideRunning a recall, and proving you could
Chapter 2 makes the RP responsible for coordinating and promptly performing recall operations. Chapter 6 sets out what the process must achieve. The part most often missing is evidence that it has ever been tested.
Operations guideReturns, and the decision to put stock back on sale
Returning stock to saleable inventory is an RP decision with a specific evidential bar. The recurring finding is not that the bar is applied badly, but that the process never reaches the RP at all.
Quality systems guideTraining records that demonstrate competence
Attendance is easy to record and proves little. The GDP expectation is a training programme that produces demonstrable competence for the task the person actually performs.
Operations guideCold chain storage and transport under GDP
Cold chain compliance rests on being able to demonstrate the temperature at every point, not on having refrigeration. The demonstration is where most findings arise.
Controlled drugs guideControlled drugs, on top of GDP
Controlled drugs sit under a separate legal framework that runs alongside GDP rather than inside it. Holding a WDA(H) does not address any of it.
GDP guideDistributing active substances under the 2015 GDP principles
Active substances have their own GDP guidelines, published in 2015 and separate from the 2013 guidelines for finished medicines. Applying the wrong document is a common and avoidable error.
AI governance guideUsing AI responsibly in MHRA GxP inspection responses
MHRA does not prohibit AI-assisted inspection responses. It expects the finished submission to be accurate, verifiable, technically reviewed, evidence-backed and approved by someone accountable.
These guides summarise published guidance to help you find the right question. They do not replace the primary sources, your own procedures, or the judgement of your Responsible Person.
READY WHEN YOU ARE
Put ANDY
beside your RP.
Start with a focused workspace for day-to-day compliance work, then bring your team and controlled knowledge with you.
View plans