A graded audit of a medicines wholesale or distribution site against the EU Guidelines on Good Distribution Practice (2013/C 343/01): quality system, personnel and the Responsible Person, premises and security, temperature mapping, monitoring and alarms, segregation of quarantined, returned and suspected falsified stock, equipment calibration and computer systems, documentation, supplier and customer checks, receipt, storage, picking and dispatch, transport and temperature in transit, returns, complaints and recalls, outsourced activities and self-inspection. Each point is graded Meets, Minor, Major or Critical, and the report ends with a corrective-action plan.
Audit Details
Which site, what it does, what kind of audit this is and who was there.
Audit title
Site audited
Site address
Your organisation
Lead auditor
Other auditors
Audit date
Kind of audit — Self-inspection, Audit of a distributor we supply or buy from, Audit of a service provider — warehouse or transport, Readiness check before a regulator's inspection, Follow-up of an earlier audit
Wholesale authorisation number
Responsible Person named on the authorisation
What the site does — Buys medicines, Holds stock, Supplies customers, Imports, Exports outside the EU, Stores for other companies, Arranges or carries out transport, Brokers without holding stock
Product classes held — Room temperature (15–25 °C), Refrigerated (2–8 °C), Frozen, Controlled drugs, Flammable or otherwise hazardous, Radiopharmaceuticals, Products at risk of theft or misuse, Investigational or unlicensed medicines
People interviewed
Scope, and the records sampled
Grade each point. Meets: nothing to report. Minor: a gap that does not by itself put a medicine or a patient at risk. Major: a real departure from the guidelines or the site's own procedures, or a run of minors that shows a system is not working. Critical: something that has caused, or could well cause, a harmful, degraded or falsified medicine to reach a patient. N/A: does not apply to this site.
Quality System
Is there a working quality system that someone senior owns?
Is the quality system written down — a quality manual or an equivalent description? — Meets, Minor, Major, Critical, N/A
Has management given the system enough people, time and money, and are responsibilities assigned? — Meets, Minor, Major, Critical, N/A
Do changes that could affect storage or distribution go through a recorded change-control process? — Meets, Minor, Major, Critical, N/A
Are deviations recorded and investigated, with corrective and preventive actions followed to closure? — Meets, Minor, Major, Critical, N/A
Is the effect of corrective actions checked afterwards? — Meets, Minor, Major, Critical, N/A
Does management review the quality system at set intervals, and are the reviews minuted? — Meets, Minor, Major, Critical, N/A
Are decisions about risk — new suppliers, routes, excursions — made with a documented risk assessment? — Meets, Minor, Major, Critical, N/A
Are quality indicators tracked, such as excursions, complaints, returns and late actions? — Meets, Minor, Major, Critical, N/A
Quality system notes
Personnel, Training and the Responsible Person
Enough trained people, clear roles, and a Responsible Person doing the job.
Is there a current organisation chart showing who reports to whom? — Meets, Minor, Major, Critical, N/A
Do people in key roles have written job descriptions that name their deputies? — Meets, Minor, Major, Critical, N/A
Are there enough competent staff at every stage, including evenings and weekends where the site works them? — Meets, Minor, Major, Critical, N/A
Is every new starter trained on GDP and their own procedures before working unsupervised? — Meets, Minor, Major, Critical, N/A
Is refresher training planned and recorded against a written programme? — Meets, Minor, Major, Critical, N/A
Does training cover spotting suspicious product and keeping falsified medicines out? — Meets, Minor, Major, Critical, N/A
Have staff handling special products — cold chain, controlled drugs, hazardous goods — had specific training? — Meets, Minor, Major, Critical, N/A
Is it checked that training worked, for example by observation, a quiz or error rates? — Meets, Minor, Major, Critical, N/A
Are there written rules on health, hygiene and clothing, and are they followed on the floor? — Meets, Minor, Major, Critical, N/A
Responsible Person. Ask to see evidence for each point — a signed approval, a decision record, a report with their name on it — not just the job description.
Is the Responsible Person formally appointed and the one named on the authorisation? — Meets, Minor, Major, Critical, N/A
Do their qualifications and experience meet what the national authority requires? — Meets, Minor, Major, Critical, N/A
Do they have a written job description that gives them the authority to act? — Meets, Minor, Major, Critical, N/A
Are they reachable whenever the site operates, with a named and trained deputy? — Meets, Minor, Major, Critical, N/A
Do they, or someone they have delegated to in writing, decide whether returned stock goes back into saleable stock? — Meets, Minor, Major, Critical, N/A
Do they approve new suppliers and customers? — Meets, Minor, Major, Critical, N/A
Do they coordinate recalls and decisions about suspected falsified product? — Meets, Minor, Major, Critical, N/A
Do they see the self-inspection reports and make sure the actions are done? — Meets, Minor, Major, Critical, N/A
Do they approve any contractor carrying out GDP work? — Meets, Minor, Major, Critical, N/A
Personnel and Responsible Person notes
Premises, Security and Hygiene
Walk the building: who can get in, where each kind of stock is kept, and how clean it is.
Grade each point. Meets: nothing to report. Minor: a gap that does not by itself put a medicine or a patient at risk. Major: a real departure from the guidelines or the site's own procedures, or a run of minors that shows a system is not working. Critical: something that has caused, or could well cause, a harmful, degraded or falsified medicine to reach a patient. N/A: does not apply to this site.
Is the storage building run by another company on the site's behalf?
Is there a written contract, and are those premises covered by a wholesale authorisation? — Meets, Minor, Major, Critical, N/A
Is entry limited to authorised people — locks, access control, visitor sign-in? — Meets, Minor, Major, Critical, N/A
Are there working intruder and fire alarms, and is someone alerted when they go off? — Meets, Minor, Major, Critical, N/A
Are the goods-in and goods-out bays covered, so stock is protected from rain, sun and cold while it is loaded? — Meets, Minor, Major, Critical, N/A
Are receiving and dispatch areas kept apart from the main storage area? — Meets, Minor, Major, Critical, N/A
Is there a separate, labelled, secure area for stock that must not be sold? — Meets, Minor, Major, Critical, N/A
On the day, was every item in that area labelled with its status, and nothing on-hold found in saleable locations? — Meets, Minor, Major, Critical, N/A
Is stock stored off the floor, on racking or pallets in good repair, with room to clean and to let air move? — Meets, Minor, Major, Critical, N/A
Are toilets, washrooms and break areas separated from the storage areas? — Meets, Minor, Major, Critical, N/A
Is it forbidden, and seen to be forbidden, to keep food, drink, smoking materials or personal medicines where stock is stored? — Meets, Minor, Major, Critical, N/A
Is there a cleaning schedule, and are cleaning records up to date? — Meets, Minor, Major, Critical, N/A
On the walk, were floors, racking and corners clean, dry and free of rubbish and dust? — Meets, Minor, Major, Critical, N/A
Are doors, seals and openings closed against birds, rodents and insects? — Meets, Minor, Major, Critical, N/A
Is there a preventive pest control contract with a bait map, visit reports and follow-up of any activity? — Meets, Minor, Major, Critical, N/A
Is there a spillage kit and a procedure for broken packs? — Meets, Minor, Major, Critical, N/A
Does the site hold controlled drugs, hazardous goods, radioactive products or products at risk of theft?
Are those products kept in dedicated areas with the extra security and safety measures they need? — Meets, Minor, Major, Critical, N/A
Are controlled drugs held under the lock, key and record arrangements national law requires? — Meets, Minor, Major, Critical, N/A
Are flammable or hazardous products stored to the fire and safety rules that apply to them? — Meets, Minor, Major, Critical, N/A
Premises photos — bays, quarantine area, racking, pest points
Premises notes
Temperature and Environment Control
Mapped, monitored, alarmed — and readings taken today in every storage area.
Are the required storage conditions for each area written down and matched to product labels? — Meets, Minor, Major, Critical, N/A
Has every storage area been temperature mapped before use, with a report someone has approved? — Meets, Minor, Major, Critical, N/A
Is mapping repeated after significant changes and at a set interval, taking account of summer and winter? — Meets, Minor, Major, Critical, N/A
Are the monitoring probes placed where the mapping found the hottest and coldest spots? — Meets, Minor, Major, Critical, N/A
Is temperature recorded continuously, and is the record reviewed at a set frequency? — Meets, Minor, Major, Critical, N/A
Do high and low alarms reach a named person at any hour, and are they tested on a schedule? — Meets, Minor, Major, Critical, N/A
When an excursion happens, is the stock quarantined, the cause investigated and a documented decision made on the product? — Meets, Minor, Major, Critical, N/A
Where products need it, are humidity and light controlled and monitored too? — Meets, Minor, Major, Critical, N/A
Is there a plan for power or plant failure — backup power, spare capacity, or a tested move to another store? — Meets, Minor, Major, Critical, N/A
Does the site store refrigerated or frozen products?
Are cold rooms and fridges built for medicines, mapped, and not overloaded or packed against the cooling unit? — Meets, Minor, Major, Critical, N/A
Are door seals intact, and do doors close by themselves or alarm when left open? — Meets, Minor, Major, Critical, N/A
Have defrost cycles been checked so they do not take the temperature out of range? — Meets, Minor, Major, Critical, N/A
Is refrigerated stock moved into cold storage first when it arrives, and picked last before dispatch? — Meets, Minor, Major, Critical, N/A
Readings taken today
Storage area or unit
Required range
Reading
Humidity, if monitored
Inside the range? — Yes, No
Display or logger photo
Monitoring system, alarm panel, mapping report
Temperature notes
Equipment and Computer Systems
Equipment that affects product kept calibrated and maintained; systems validated and secure.
Is there a list of the equipment that can affect product quality — monitoring, cooling, alarms, handling? — Meets, Minor, Major, Critical, N/A
Are monitoring devices calibrated against a traceable standard at least once a year? — Meets, Minor, Major, Critical, N/A
Are calibration certificates on file, with any out-of-tolerance result assessed for its effect on stock? — Meets, Minor, Major, Critical, N/A
Is cooling plant, alarm equipment and handling equipment serviced to a plan, with records? — Meets, Minor, Major, Critical, N/A
Are breakdowns and repairs logged, and is equipment requalified after a significant repair? — Meets, Minor, Major, Critical, N/A
Is racking inspected at set intervals and damage dealt with? — Meets, Minor, Major, Critical, N/A
Were the stock and monitoring systems validated before use, with evidence kept? — Meets, Minor, Major, Critical, N/A
Is there a written description of each system — what it does, how it connects, who looks after it? — Meets, Minor, Major, Critical, N/A
Is access controlled by personal log-ins and roles, with leavers removed promptly? — Meets, Minor, Major, Critical, N/A
Are changes to records traceable — who changed what, when and why? — Meets, Minor, Major, Critical, N/A
Is data backed up regularly to a separate place, and has a restore been tested? — Meets, Minor, Major, Critical, N/A
Is there a written fallback for when the system is down? — Meets, Minor, Major, Critical, N/A
Equipment and systems notes
Documentation
Procedures that are current and followed; records that are complete and kept.
Are there written procedures for every GDP activity, approved, signed and dated? — Meets, Minor, Major, Critical, N/A
Are procedures version-controlled and reviewed on schedule, with superseded copies withdrawn? — Meets, Minor, Major, Critical, N/A
Can staff reach the current version where they work, in a language they understand? — Meets, Minor, Major, Critical, N/A
On the floor, did what people do match what the procedure says? — Meets, Minor, Major, Critical, N/A
Are records made at the time of the activity, legible and in permanent form? — Meets, Minor, Major, Critical, N/A
Are corrections dated, signed and leave the original readable? — Meets, Minor, Major, Critical, N/A
Are records kept for at least five years, or longer where national rules say so? — Meets, Minor, Major, Critical, N/A
Does every purchase and sale record carry the details the guidelines list? — Meets, Minor, Major, Critical, N/A
Documentation notes
Suppliers and Customers
Medicines bought only from, and sold only to, those entitled to deal in them.
Before buying, is each supplier's wholesale or manufacturing authorisation checked on the official database? — Meets, Minor, Major, Critical, N/A
Is the due diligence on each supplier recorded, including its reputation and history? — Meets, Minor, Major, Critical, N/A
Are suppliers re-checked at set intervals, not just once? — Meets, Minor, Major, Critical, N/A
Where brokers are used, are they registered? — Meets, Minor, Major, Critical, N/A
Is there a procedure for offers that look wrong — unusual price, stock of a product in shortage, odd origin? — Meets, Minor, Major, Critical, N/A
Before supplying, is it confirmed that each customer is authorised or entitled to receive medicines? — Meets, Minor, Major, Critical, N/A
Are unusual orders — sudden volumes, products outside a customer's normal range — spotted and investigated? — Meets, Minor, Major, Critical, N/A
Are supplies of controlled or restricted products limited to customers entitled to them? — Meets, Minor, Major, Critical, N/A
Supplier and customer notes — list the files sampled
Receipt of Goods
At goods-in: the right product, in the right condition, held until released.
Is each delivery checked against the order and the supplier's paperwork? — Meets, Minor, Major, Critical, N/A
Are the vehicle, seals and packaging checked for damage, tampering or contamination on arrival? — Meets, Minor, Major, Critical, N/A
Are refrigerated deliveries dealt with first, and the transit temperature record checked before acceptance? — Meets, Minor, Major, Critical, N/A
Are safety features verified where the product carries them? — Meets, Minor, Major, Critical, N/A
Are batch numbers and expiry dates recorded on receipt? — Meets, Minor, Major, Critical, N/A
Is damaged, doubtful or unexpected stock put in quarantine rather than into stock? — Meets, Minor, Major, Critical, N/A
Is stock blocked for sale until it has been checked and released? — Meets, Minor, Major, Critical, N/A
Is accepted stock moved to its storage location promptly? — Meets, Minor, Major, Critical, N/A
Goods-in photos
Receipt notes
Storage, Stock Control and Destruction
Stock kept to its label, rotated, counted, and disposed of properly when it must go.
Is every product stored at the conditions its label requires? — Meets, Minor, Major, Critical, N/A
Is stock picked first-expiry-first-out, and does the system enforce it? — Meets, Minor, Major, Critical, N/A
Is short-dated and expired stock found and removed from saleable stock in time? — Meets, Minor, Major, Critical, N/A
Are stock counts done regularly, with differences investigated? — Meets, Minor, Major, Critical, N/A
Are damaged packs withdrawn from saleable stock straight away? — Meets, Minor, Major, Critical, N/A
Are products kept so they cannot contaminate or be confused with one another? — Meets, Minor, Major, Critical, N/A
On the walk, was every pallet and pack in its proper location, labelled and in date? — Meets, Minor, Major, Critical, N/A
Is stock for destruction labelled, held apart and recorded? — Meets, Minor, Major, Critical, N/A
Is it destroyed by an authorised contractor, in line with national and waste rules? — Meets, Minor, Major, Critical, N/A
Are destruction certificates kept and reconciled with what was sent? — Meets, Minor, Major, Critical, N/A
Storage photos
Storage notes
Picking, Packing and Dispatch
The right product, with enough shelf life, packed and labelled for the journey.
Is the picked product checked against the order before packing? — Meets, Minor, Major, Critical, N/A
Does the product sent have enough shelf life left for the customer? — Meets, Minor, Major, Critical, N/A
Is the packaging chosen for the journey? — Meets, Minor, Major, Critical, N/A
Are shipping containers sealed? — Meets, Minor, Major, Critical, N/A
Do containers carry labels that identify them and give the handling and storage conditions? — Meets, Minor, Major, Critical, N/A
Does a document travel with each delivery giving what the guidelines list? — Meets, Minor, Major, Critical, N/A
Does the site export medicines outside the EU?
Is it confirmed that each export customer is authorised to receive medicines under the law of the receiving country? — Meets, Minor, Major, Critical, N/A
Does the site hold the authorisation needed to export? — Meets, Minor, Major, Critical, N/A
Are export records complete and kept like other sales? — Meets, Minor, Major, Critical, N/A
Conditions held from the dock to the customer, by your own vehicles or a carrier's.
Who carries the goods — Own vehicles, Contracted carrier, Both, Courier or parcel network, Customer collects
Is product kept within its labelled conditions throughout transport? — Meets, Minor, Major, Critical, N/A
Are vehicles clean, secure, kept in good repair and suitable for medicines? — Meets, Minor, Major, Critical, N/A
Where vehicles also carry other goods, are there controls so medicines are not put at risk? — Meets, Minor, Major, Critical, N/A
Are temperature devices used in transit calibrated at least once a year? — Meets, Minor, Major, Critical, N/A
Is transit temperature data reviewed, and kept with the delivery record? — Meets, Minor, Major, Critical, N/A
Are excursions in transit reported to the distributor and the customer, and investigated? — Meets, Minor, Major, Critical, N/A
Where needed, is the manufacturer asked what to do with product affected by a deviation? — Meets, Minor, Major, Critical, N/A
Is there a written plan for a breakdown, an accident or a failed delivery? — Meets, Minor, Major, Critical, N/A
Have drivers, including agency and contract drivers, been trained in the parts of GDP that affect them? — Meets, Minor, Major, Critical, N/A
Are goods delivered only to the address on the delivery note and handed to the customer's staff, never left elsewhere? — Meets, Minor, Major, Critical, N/A
Does the site ship products that need refrigeration or insulated packing?
Have temperature-controlled vehicles been mapped under realistic conditions, summer and winter? — Meets, Minor, Major, Critical, N/A
Are insulated boxes packed to a qualified layout for the season? — Meets, Minor, Major, Critical, N/A
Are cool packs conditioned correctly and kept from touching the product? — Meets, Minor, Major, Critical, N/A
Are packing staff trained on the box layouts and on when cool packs can be reused? — Meets, Minor, Major, Critical, N/A
Is there a written procedure for sending temperature-sensitive products, including seasonal changes? — Meets, Minor, Major, Critical, N/A
Does the goods' journey pass through hubs or cross-docks where they wait?
Is there a current list of the hubs used, with a specification each must meet? — Meets, Minor, Major, Critical, N/A
Was each hub assessed and approved before it was used? — Meets, Minor, Major, Critical, N/A
Is there a maximum time goods may wait at a hub? — Meets, Minor, Major, Critical, N/A
For controlled or high-risk products, is transport secure and dedicated, with the extra checks national rules require? — Meets, Minor, Major, Critical, N/A
Vehicle, load space, logger and packaging photos
Transport notes
Returns, Complaints, Falsified Medicines and Recalls
Bad stock caught and kept out; good stock only returned to sale with evidence.
Is there a written returns procedure with a time limit for accepting returns? — Meets, Minor, Major, Critical, N/A
Are returns held in quarantine until a decision is made and recorded? — Meets, Minor, Major, Critical, N/A
Before anything goes back to saleable stock, is it confirmed to be unopened, undamaged, in date, not recalled and kept in proper conditions? — Meets, Minor, Major, Critical, N/A
Are refrigerated returns refused for resale unless there is evidence they stayed in range throughout? — Meets, Minor, Major, Critical, N/A
Is the decision to return to stock made by the Responsible Person or someone they have authorised? — Meets, Minor, Major, Critical, N/A
Is returned stock put back so first-expiry-first-out still works? — Meets, Minor, Major, Critical, N/A
Is stock that was stolen and recovered kept out of saleable stock? — Meets, Minor, Major, Critical, N/A
Are all complaints recorded, with quality complaints told apart from distribution complaints? — Meets, Minor, Major, Critical, N/A
Are complaints investigated for the cause, with any wider effect on other batches considered? — Meets, Minor, Major, Critical, N/A
Are product quality complaints passed to the manufacturer or marketing authorisation holder without delay? — Meets, Minor, Major, Critical, N/A
Are suspected falsified medicines removed from stock at once and held apart? — Meets, Minor, Major, Critical, N/A
Are they reported to the competent authority and the marketing authorisation holder? — Meets, Minor, Major, Critical, N/A
Is there a written recall procedure that works out of hours? — Meets, Minor, Major, Critical, N/A
Can the site list every customer who received a given batch, quickly? — Meets, Minor, Major, Critical, N/A
Has a recall been tested, or carried out, within the last year, and was the result recorded? — Meets, Minor, Major, Critical, N/A
Are recalled quantities reconciled and the outcome reported? — Meets, Minor, Major, Critical, N/A
Returns, complaints and recall notes
Outsourced Activities
Work handed to contractors stays under the site's control.
Is any GDP work contracted out?
What is contracted out — Storage, Transport, Calibration, Pest control, Cleaning, IT systems, Destruction, Temperature mapping
Is there a written agreement for each, setting out who is responsible for what? — Meets, Minor, Major, Critical, N/A
Was each contractor assessed as competent, and authorised where the law requires, before work began? — Meets, Minor, Major, Critical, N/A
Is their performance reviewed, including audits at set intervals? — Meets, Minor, Major, Critical, N/A
Is subcontracting by them allowed only with the site's written approval? — Meets, Minor, Major, Critical, N/A
Have contractors been given what they need to do the work properly — product requirements, procedures, contacts? — Meets, Minor, Major, Critical, N/A
Outsourcing notes
Self-Inspection
The site checks itself, and finishes what it finds.
Is there a self-inspection programme covering every part of GDP within a set period? — Meets, Minor, Major, Critical, N/A
Are self-inspections done impartially, by competent people? — Meets, Minor, Major, Critical, N/A
Are they recorded, with observations and proposed actions? — Meets, Minor, Major, Critical, N/A
Are the actions from earlier self-inspections and external audits closed on time? — Meets, Minor, Major, Critical, N/A
Do the results reach senior management? — Meets, Minor, Major, Critical, N/A
Self-inspection notes
Summary and Sign-off
Count the findings by class, agree the actions, and sign.
Number of critical findings
Number of major findings
Number of minor findings
Overall outcome — Acceptable, Acceptable — actions to complete, Not acceptable — re-audit needed
Responsible Person or site representative — signature
Transport & Equipment
GDP Audit Checklist
A graded audit of a medicines wholesale or distribution site against the EU Guidelines on Good Distribution Practice (2013/C 343/01): quality system, personnel and the Responsible Person, premises and security, temperature mapping, monitoring and alarms, segregation of quarantined, returned and suspected falsified stock, equipment calibration and computer systems, documentation, supplier and customer checks, receipt, storage, picking and dispatch, transport and temperature in transit, returns, complaints and recalls, outsourced activities and self-inspection. Each point is graded Meets, Minor, Major or Critical, and the report ends with a corrective-action plan.
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This form audits the storage and movement of finished medicines. If you are auditing the site where they are made, use: GMP audit checklist
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A GDP audit checks whether a site that buys, holds and supplies medicines keeps them in the condition the manufacturer released them in, and keeps falsified product out, all the way to the customer's door. This checklist follows the order of the EU Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01), but walks the building the way stock moves through it: goods-in, storage, picking, dispatch and the vehicle, with the quality system and records on either side. Each point is graded Meets, Minor, Major or Critical, and the report ends with the findings counted by class and an action plan with owners and dates. Fill it in here and download a PDF without an account, or speak while you walk, and the document writes itself.
Who uses a GDP audit checklist
Three kinds of people do this audit. A wholesaler's own quality team uses it for the self-inspection the guidelines expect. A manufacturer or marketing authorisation holder uses it to qualify a distributor, a third-party warehouse or a transport company before handing over stock. And a consultant uses it before a regulator's inspection to find the gaps first.
It is not the regulator's inspection, and finishing it does not make a site compliant. It records what the auditor saw, read and was told on the day, graded, with evidence attached.
How findings are graded
The grades follow the way GDP auditors and inspectors usually class observations. A Critical finding is one that has produced, or could well produce, a medicine that harms a patient — a cold room alarm nobody answers, recalled stock still in pick faces, a supplier whose authorisation was never checked. A Major is a significant departure from the guidelines or the site's own procedures without that immediate risk, or several minors that together show a system is not working. A Minor is a gap that matters but does not by itself put product at risk.
In the report, Criticals are listed first as safety findings, Majors as repairs and Minors as items to monitor, so the reader sees what needs action this week before the paperwork tidy-ups.
Temperature: mapping, monitoring and transit
Most serious GDP findings come back to temperature. The checklist asks whether each storage area has been mapped and the monitoring probes placed where the mapping says the extremes are, whether alarms reach a person out of hours and have been tested, and whether excursions are investigated with the stock quarantined until someone decides. It then asks you to take readings on the day, area by area, and record whether each was inside its range.
Transport gets the same treatment: vehicles or packaging qualified for the conditions and the season, monitoring devices calibrated, data looked at on arrival, and a plan for a breakdown. The cold chain questions appear only if the site stores or ships refrigerated products.
Returns, falsified medicines and recalls
Returned stock is where good product and bad product are most easily mixed. The checklist asks whether returns are held apart until an authorised person decides, what evidence is needed before anything goes back into saleable stock, and whether refrigerated returns are refused without proof of their conditions. Suspected falsified packs must be pulled aside and reported at once.
For recalls, the questions are practical: can the site find every customer who received a batch, act out of hours, and show a test recall done in the last year.
The Responsible Person
Every wholesale authorisation names a Responsible Person who answers for GDP on that site. Rather than one line asking whether they "fulfil their duties", the checklist breaks the role into the things you can actually see: their qualifications against national requirements, a written job description and a deputy, and evidence that they approve returns to stock, sign off suppliers and customers, lead recalls and see the self-inspection reports.
Common questions
What is a GDP audit?
A structured check of a medicines distribution site — wholesaler, third-party warehouse or transport provider — against Good Distribution Practice. It covers the quality system, people, premises, temperature control, documentation, operations, returns and recalls, outsourcing, self-inspection and transport.
What is the difference between a critical, major and minor GDP finding?
A critical finding has caused, or carries a significant risk of causing, a harmful or falsified product reaching a patient. A major is a significant departure from GDP or the site's procedures without that immediate risk, or a cluster of minors showing a failing system. A minor is a departure that does not on its own put product quality at risk. This form records the class against each point and counts them in the close-out.
Which guidelines does this checklist follow?
Its order follows the EU Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01). National rules and the competent authority's own guidance sit on top of that, so add anything your country requires in the notes for each section.
How often should a GDP self-inspection be done?
The guidelines expect a self-inspection programme covering every aspect of GDP within a defined period, without fixing one interval. Many wholesalers cover the whole site once a year, with high-risk areas such as cold chain and returns looked at more often.
Can I use it to audit a transport company or third-party warehouse?
Yes. Set the audit type to a service-provider audit, answer N/A to the points that do not apply to them, and use the outsourced-activities and transport sections in full. The graded findings then feed your decision to approve, approve with conditions or not approve them.
Does completing this checklist make a site GDP compliant?
No. It records what the auditor checked and found on one day. Compliance is decided by the competent authority against the guidelines and national law, and depends on the systems working every day, not on the day of the audit.