MHRA GDP inspection checklist: every section of the GDP guidelines, with what to check and the evidence an inspector asks for
A self-inspection tool for wholesale dealer's licence holders, set out the way the GDP guidelines are: nine chapters, 32 sections, and for each one the checks to run and the evidence to have ready. Browse all 32 below, or request a copy tailored to your site and we'll send a scoped working template.
The GDP guidelines require your own self-inspection programme. Chapter 8 says "A self-inspection programme should be implemented covering all aspects of GDP and compliance with the regulations, guidelines and procedures within a defined time frame". This checklist covers every section of chapters 1 to 9, which apply to every wholesaler.
The chapter principles and section titles are quoted from the GDP guidelines, EU wording included. The "what to check" and "evidence to have ready" columns are ours. We wrote the checks from each section's text, and the evidence column draws on the aide-memoire GDP inspectors use (PIC/S PI 044-1). Use them as prompts for your own self-inspection.
In Great Britain, the Human Medicines Regulations 2012 (regulation 43) require every wholesale dealer's licence holder to follow the GDP guidelines, and the 2013 guidelines apply under regulation C17 until MHRA replaces them. Licence holders in Northern Ireland follow the European Commission's guidelines, which are still the same 2013 text. You'll find every source under Sources, below the tables.
Last reviewed: 7 October 2026.
Nothing on this page is regulatory advice: see the terms of use. For a working copy you can fill in, request one tailored to your site below.
Brokering medicines? Chapter 10 of the guidelines sets extra rules for brokers, and this checklist doesn't cover them.
Also registered with CQC or GPhC? Browse all our free tools, including the GPhC inspection checklist.
Chapter 1: Quality management 4 sections
Principle: "Wholesale distributors must maintain a quality system setting out responsibilities, processes and risk management principles in relation to their activities. All distribution activities should be clearly defined and systematically reviewed. All critical steps of distribution processes and significant changes should be justified and where relevant validated. The quality system is the responsibility of the organisation’s management and requires their leadership and active participation and should be supported by staff commitment."
| Section | What to check | Evidence to have ready |
|---|---|---|
| 1.2Quality system | Is your quality system written down in a quality manual or equivalent, covering your structure, procedures, processes and resources, and do you monitor whether it works? Check management has appointed a Responsible Person with clear authority over the quality system, and resourced it with enough competent people, premises and equipment. Check you run change control using quality risk management, record and investigate deviations from procedures, and take corrective and preventive actions (CAPA). Check your team makes records at the time and products reach the right recipients within a satisfactory time. | Your quality manual; the change control procedure and a log of changes since your last inspection; the deviation procedure and log, with the CAPA for each; and records showing how you monitor whether the quality system works. |
| 1.3Management of outsourced activities | Does your quality system cover every activity you outsource, such as storage or transport? Check you assessed each contractor's suitability and competence before using them, and checked their licence where they need one. Check you agreed who does what on quality and how you communicate, and that you review each contractor's performance and act on what you find. | A list of the GDP activities you outsource, how you approved each provider, and records of your reviews of their performance. |
| 1.4Management review and monitoring | Does management review the quality system on a set cycle, through a formal process? Check each review looks at your quality objectives and performance indicators: complaints, deviations, CAPA, changes, feedback on outsourced activities, self-inspections, risk assessments, audits, inspection findings and customer audits. Check it also covers new regulations and guidance, possible improvements and changes in your business, and that you record the outcome promptly and share it internally. | Your management review procedure, the minutes or report of each review, and how you shared the outcome. |
| 1.5Quality risk management | Do you have a procedure for assessing, controlling, communicating and reviewing risks to product quality, and do you use it in change control, deviations, complaints and outsourcing? Check each risk assessment draws on scientific knowledge and experience, links back to protecting patients, and has a level of effort and documentation that matches the risk. ICH Q9 gives worked examples. | Your quality risk management procedure and the risk assessments behind your key decisions. |
Chapter 2: Personnel 4 sections
Principle: "The correct distribution of medicinal products relies upon people. For this reason, there must be sufficient competent personnel to carry out all the tasks for which the wholesale distributor is responsible. Individual responsibilities should be clearly understood by the staff and be recorded."
| Section | What to check | Evidence to have ready |
|---|---|---|
| 2.2Responsible person | Have you named a Responsible Person who meets the qualifications and conditions national law sets, with GDP knowledge, training and experience? Check they carry out their duties personally, stay contactable at all times, and have a written job description that sets out their authority to decide. Check they have the authority and resources to run the quality system, oversee records, run training, coordinate recalls, deal with complaints, approve suppliers, customers and subcontracted activities, run self-inspections on a planned programme, record any duties they delegate, decide what happens to returned, rejected, recalled or falsified products, and approve returns to saleable stock. | The Responsible Person's job description and training records, a record of any duties they've delegated, and their sign-off on supplier and customer approvals, returns and recalls. |
| 2.3Other personnel | Do you have enough competent staff for the volume and scope of your activities? Check your organisation chart shows every role, responsibility and reporting line, and that key positions have written job descriptions with deputies named. | Your organisation chart and the job descriptions for key positions, including who deputises for whom. |
| 2.4Training | Has everyone involved in distribution had GDP training before starting their role, then continuing training under a written programme and procedures? Check training covers identifying products and keeping falsified medicines out of the supply chain, and that staff who handle controlled drugs, temperature-sensitive, hazardous or radioactive products get specific training. Check the Responsible Person keeps up their own GDP training, you keep records of all training, and you assess and record whether it works. | The training programme, training records for each person, records of how you assessed whether training worked, and training on each updated procedure. |
| 2.5Hygiene | Do you have procedures for staff health, hygiene and clothing that fit the work you do, and does the team follow them? | Your hygiene procedure covering health, hygiene and clothing. |
Chapter 3: Premises and equipment 5 sections
Principle: "Wholesale distributors must have suitable and adequate premises, installations and equipment, so as to ensure proper storage and distribution of medicinal products. In particular, the premises should be clean, dry and maintained within acceptable temperature limits."
| Section | What to check | Evidence to have ready |
|---|---|---|
| 3.2Premises | Are your premises secure, structurally sound, well lit and big enough to store and handle products safely, and do they keep products in their required storage conditions? Check you store products in clearly marked areas with access limited to authorised staff, keep falsified, expired, recalled and rejected products physically apart in a dedicated area, and segregate returns and products awaiting a decision, physically or through a validated electronic system. Check you physically segregate products that aren't authorised for your market. Check controlled drugs, hazardous and flammable products and medicinal gases sit in dedicated areas under the relevant law, loading bays protect products from the weather, an intruder alarm and access control keep out unauthorised people, someone accompanies every visitor, and you have cleaning and pest control programmes with records. If someone else runs premises for you, check you have a contract and that those premises hold their own wholesale licence. | A floor plan showing segregated areas, your procedures for controlling goods in and out, alarm and access control records, cleaning and pest control records, and, for any contracted premises, the contract and their licence. |
| 3.2.1Temperature and environment control | Do you monitor temperature, light, humidity and cleanliness where you store products? Check you mapped temperatures in each storage area before use, under representative conditions, placed monitors where the mapping found the extremes, and repeat the mapping when a risk assessment says so or after significant changes to the building or the temperature control equipment. In small rooms kept at room temperature, check you assessed risks such as heaters and placed monitors to match. | Temperature mapping reports for each storage area, fridge and cold room, continuous monitoring records, and your procedure and records for temperature excursions. |
| 3.3Equipment | Do you maintain key equipment on a plan, including cold stores, fridges, temperature and humidity recorders, alarm and access systems, and air handling units? Check you calibrate monitoring equipment at intervals set by a risk and reliability assessment, traceable to a national or international standard. Check alarms alert you when storage conditions go out of range, you set the alarm levels appropriately and test the alarms regularly, and repairs, maintenance and calibration never put products at risk. | Planned maintenance and calibration schedules, calibration certificates, alarm test records, and repair and maintenance records for key equipment. |
| 3.3.1Computerised systems | Did you validate or verify each computerised system before use, and do you keep an up-to-date written description of it, with diagrams where useful? Check only authorised people can enter or change data, you protect data against accidental or unauthorised changes, you check stored data stays accessible, and you back it up regularly, keeping backups at a separate, secure location for the period national law sets and at least five years. Check you have procedures for system failure, including restoring data. | A list of your computerised systems with their validation records and descriptions, user access controls, backup records, and your procedure for system failure and data recovery. |
| 3.3.2Qualification and validation | Did you use a documented risk assessment to decide which key equipment to qualify and which processes, such as storage and pick and pack, to validate? Check you qualify or validate before first use and after significant changes such as repairs, write reports that summarise the results and any deviations, take CAPA where needed, and have the right people approve the outcome. | The risk assessments, approved qualification and validation reports, and your criteria for requalification and revalidation. |
Chapter 4: Documentation 1 section
Principle: "Good documentation constitutes an essential part of the quality system. Written documentation should prevent errors from spoken communication and permits the tracking of relevant operations during the distribution of medicinal products."
| Section | What to check | Evidence to have ready |
|---|---|---|
| 4.2General | Are your procedures, instructions, contracts and records easy to find, clear, free from errors and in a language your staff understand? Check the Responsible Person approves, signs and dates procedures, you apply version control, review documents regularly and remove superseded versions from workstations. Check every change to a record is signed and dated and leaves the original readable, you keep documents for the period national law sets and at least five years, and you delete or anonymise personal data once you no longer need it. Check you record every transaction at the time, with the date, product name, quantity, supplier or customer name and address, and the batch number at least for products with safety features. | An index of procedures with version history, purchase and sales invoices and delivery records showing full traceability from purchase to onward sale, and your archive. |
Chapter 5: Operations 8 sections
Principle: "All actions taken by wholesale distributors should ensure that the identity of the medicinal product is not lost and that the wholesale distribution of medicinal products is performed according to the information on the outer packaging. The wholesale distributor should use all means available to minimise the risk of falsified medicinal products entering the legal supply chain. All medicinal products distributed in the EU by a wholesale distributor must be covered by a marketing authorisation granted by the EU or by a Member State. Any distributor, other than the marketing authorisation holder, who imports a medicinal product from another Member State must notify the marketing authorisation holder and the competent authority in the Member State to which the medicinal product will be imported of their intention to import that product. All key operations described below should be fully described in the quality system in appropriate documentation."
| Section | What to check | Evidence to have ready |
|---|---|---|
| 5.2Qualification of suppliers | Do you buy medicines only from companies that hold a wholesale dealer's licence, or a manufacturer's licence that covers the product? Check you approved each supplier before your first order, using a written procedure, and recheck them regularly. Check you confirmed each wholesale supplier's licence and GDP compliance, for example on MHRA's GMDP database in Great Britain or the EU's EudraGMDP database (the "Union database" the guidelines name), and that any broker you buy through is registered. For each new supplier, check you carried out due diligence on their reputation and on offers that look wrong: products more likely to be falsified, large quantities of products usually only available in small amounts, or prices out of range. If you import, check you hold the right authorisation: in the EU, importing from third countries needs a manufacturing authorisation; in Great Britain, a wholesale dealer's licence can cover imports of QP-certified medicines from countries on MHRA's approved country for import list if it names a Responsible Person (import). | Your approved supplier list, the procedure you follow to approve a supplier, a dated record for each supplier of the licence check, the GDP check and the due diligence, and records of each recheck. Be ready to show the inspector how you stop an order going to a supplier you haven't approved. |
| 5.3Qualification of customers | Do you supply only to people who hold a wholesale licence or who are authorised or entitled to supply medicines to the public? Check you verify this before the first supply and recheck it regularly, for example by asking for copies of their authorisations or checking an authority's website. Check you monitor sales of controlled drugs and other dangerous substances, investigate unusual patterns that could mean diversion or misuse, and report them to the authorities where necessary. Check you meet any public service obligations. | Your list of qualified customers, the procedure for opening an account, a record of the checks on each customer, and your monitoring of sales of products at risk of diversion. |
| 5.4Receipt of medicinal products | Do you check each delivery against the order, confirm it comes from an approved supplier, and look for transport damage? Check you move products that need special storage or security into the right storage straight after the checks, and that whoever receives goods considers whether they could be falsified. Check you keep each batch out of saleable stock until you've confirmed, under a written procedure, that it's authorised for sale. For batches from another EU Member State, check trained staff review the control report or equivalent proof of release; in Great Britain, imports from approved countries go through your Responsible Person (import)'s checks. | Your goods-in procedure, receipt records, transport temperature records for products with storage requirements, and how you handle goods that fail the checks. |
| 5.5Storage | Do you store medicines away from products that could alter them, protected from light, temperature, moisture and other external factors? Check you rotate stock first expiry, first out and document any exceptions, keep products off the floor unless the packaging allows it, and move short-dated stock out of saleable stock straight away. Check you count stock regularly and investigate and record any discrepancies. | Your stock rotation and short-dated stock procedures, stock count records, and investigations of discrepancies. |
| 5.6Destruction of obsolete goods | Do you label products for destruction, keep them apart and handle them under a written procedure? Check destruction follows national or international requirements and you keep records of everything destroyed for a defined period. | The destruction procedure, the labelled area for these products, and destruction records. |
| 5.7Picking | Do you have controls that make sure the team picks the right product, with enough shelf life left? | Your picking procedure and checks, including how you confirm remaining shelf life. |
| 5.8Supply | Does every delivery go with a document such as a delivery note, showing the date, product name and form, batch number at least for products with safety features, quantity, supplier name and address, the consignee's name and delivery address, and transport and storage conditions? Check your records show where each product actually is. | Sample delivery notes and supply records. |
| 5.9Export to third countries | If you export, does your wholesale or manufacturing licence cover it, including from a free zone? Check you apply every wholesale rule to exports, stop exported products that lack a marketing authorisation for your own market from reaching it, and supply only people in the destination country who are authorised or entitled to receive medicines there. | Your export procedure and the checks on each overseas customer's authorisation. |
Chapter 6: Complaints, returns, suspected falsified medicinal products and medicinal product recalls 4 sections
Principle: "All complaints, returns, suspected falsified medicinal products and recalls must be recorded and handled carefully according to written procedures. Records should be made available to the competent authorities. An assessment of returned medicinal products should be performed before any approval for resale. A consistent approach by all partners in the supply chain is required in order to be successful in the fight against falsified medicinal products."
| Section | What to check | Evidence to have ready |
|---|---|---|
| 6.2Complaints | Do you record complaints with all the original details, and tell quality complaints apart from distribution complaints? Check you tell the manufacturer or marketing authorisation holder straight away about a possible product defect, investigate distribution complaints to find the cause, and take follow-up actions, including CAPA and notifying the authorities where required. Check you've named a person to handle complaints, with enough support. | The complaints procedure, the complaints log and investigation records, and how you escalate product quality defects. |
| 6.3Returned medicinal products | Do you handle returns under a written, risk-based process? Check you return a product to saleable stock only when it's in unopened, undamaged packaging, in date and not recalled; returns from customers without a wholesale licence, or from pharmacies, come back within an acceptable time, for example 10 days; the customer has shown they stored and handled it correctly; a trained, authorised person has examined it; and you have evidence you supplied it, with the batch number for products with safety features, and no reason to suspect falsification. For products that need low-temperature storage, check you hold documented evidence they stayed in their storage conditions the whole time, with a risk assessment for any deviation. Check returned stock goes back into first expiry, first out order, and recovered stolen products never go back into saleable stock. | The returns procedure, the returns log with each assessment and decision, and temperature evidence for cold-chain returns. |
| 6.4Falsified medicinal products | Do you have a procedure to tell the competent authority (in Great Britain, MHRA) and the marketing authorisation holder straight away when you find or suspect a falsified medicine? Check you record each case with all the original details, investigate it, move the products straight into a dedicated segregated area, and keep records of everything you do. | Your falsified medicines procedure, your list of products at higher risk of falsification, records of suspected cases, and how you report suspicious offers. |
| 6.5Medicinal product recalls | Can you start a recall promptly, at any time? Check you test how well your recall arrangements work at least once a year, follow the instructions in each recall message, record each recall as you carry it out, and keep a progress record for a final report. Check your distribution records give the people running a recall the details of every customer you supplied, with in-hours and out-of-hours contacts, batch numbers at least for products with safety features, and quantities, including exports and samples. | The recall procedure, records of recalls you've received and carried out, final reports, and the results of your annual recall test. |
Chapter 7: Outsourced activities 2 sections
Principle: "Any activity covered by the GDP guide that is outsourced should be correctly defined, agreed and controlled in order to avoid misunderstandings which could affect the integrity of the product. There must be a written contract between the contract giver and the contract acceptor which clearly establishes the duties of each party."
| Section | What to check | Evidence to have ready |
|---|---|---|
| 7.2Contract giver | Did you check each contractor's competence before they started, and do your contracts and audits make sure they follow GDP? Check you audit each contractor before work starts and after any change to the outsourced activity, at a frequency set by risk, that the contract allows audits at any time, and that you give the contractor all the information they need. | Contracts or quality agreements with each provider, your audit schedule, and audit reports. |
| 7.3Contract acceptor | If you carry out GDP work for others, do you have the premises, equipment, procedures, knowledge and competent staff to do it? Check you pass no work to a third party without the contract giver's approval and an audit of that third party, and that you tell the contract giver about anything that could affect product quality. | Your contracts, approvals for any subcontracting, and records of quality information you've passed to the contract giver. |
Chapter 8: Self-inspections 1 section
Principle: "Self-inspections should be conducted in order to monitor implementation and compliance with GDP principles and to propose necessary corrective measures."
| Section | What to check | Evidence to have ready |
|---|---|---|
| 8.2Self-inspections | Do you have a self-inspection programme that covers every part of GDP, the regulations and your own procedures within a set time frame? Check competent, impartial staff carry out each self-inspection in detail, record every observation, share the report with management, find the cause of each deficiency, and document and follow up the CAPA. If you use external auditors, check you still run your own self-inspections. | Your self-inspection procedure and plan, completed reports, and records showing each CAPA closed and checked for effectiveness. |
Chapter 9: Transportation 3 sections
Principle: "It is the responsibility of the supplying wholesale distributor to protect medicinal products against breakage, adulteration and theft, and to ensure that temperature conditions are maintained within acceptable limits during transport. Regardless of the mode of transport, it should be possible to demonstrate that the medicines have not been exposed to conditions that may compromise their quality and integrity. A risk-based approach should be utilised when planning transportation."
| Section | What to check | Evidence to have ready |
|---|---|---|
| 9.2Transportation | Do products stay within their storage conditions throughout transport, and do you have a procedure to investigate temperature excursions and report excursions or damage to the distributor and the recipient? Check your vehicles and equipment are suitable, cleaned and maintained under written procedures, you risk-assess delivery routes to decide where you need temperature control, and you calibrate in-vehicle temperature monitors at least once a year. Check you deliver only to the address on the delivery note, into the consignee's care, and that you have named people and procedures for out-of-hours emergency deliveries. If a third party transports for you, check the contract meets chapter 7, they know the transport conditions, and you control temperature, cleanliness and security at any transit hub. | Temperature data for sample shipments, vehicle maintenance and calibration records, route risk assessments, and contracts with any transport provider. |
| 9.3Containers, packaging and labelling | Do you choose containers and packaging based on each product's storage needs, the volume, expected outside temperatures and the longest likely journey, including time at customs? Check you qualified the packaging and validated the shipping containers, and that labels show handling and storage requirements and identify the contents and the source. | Qualification records for each packaging configuration, and sample transport labels. |
| 9.4Products requiring special conditions | For controlled drugs and other products that need special conditions, do you have extra delivery controls and a protocol for theft, in line with national law? Check highly active and radioactive products travel in safe, dedicated and secure containers and vehicles. For temperature-sensitive products, check you use qualified packaging or vehicles, map temperature-controlled vehicles with seasonal variation in mind, keep cool packs from touching products, train staff on packing insulated boxes and reusing cool packs, control cool-pack reuse, and keep frozen and chilled packs apart. Check you can show customers, on request, that products stayed in their storage conditions. | Your procedures for controlled drug and temperature-sensitive deliveries, vehicle mapping reports, seasonal packing instructions, and cool-pack control records. |
How MHRA grades what it finds
MHRA grades each deficiency it finds as critical, major or other.
- Critical: any departure from good distribution practice that results in a significant risk to patients, including an activity that increases the risk of counterfeit medicines reaching patients.
- Major: includes a major deviation from GDP or the terms of the wholesale licence, or the Responsible Person failing to fulfil their legal duties. Several "other" deficiencies together can add up to a major one.
- Other: a departure from good distribution practice that isn't critical or major.
What follows the inspection
At the closing meeting, the inspector discusses any deficiencies and agrees timelines for corrective actions. You then get a post-inspection letter and reply by email with your corrective actions and dates. If the inspector accepts your response, you receive a GDP certificate with your inspection report.
Your GDP risk score, based on what your site does and the number and type of deficiencies, sets the likely date of your next inspection. If an inspector finds critical deficiencies, or finds you haven't resolved actions from a previous inspection, they refer you to MHRA's Inspection Action Group, which can refuse or suspend a licence, increase inspections or meet the licence holder.
Sources for the guidelines and the checks
- EUR-Lex: Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01)
- legislation.gov.uk: Human Medicines Regulations 2012, regulation 43 (obligations of licence holder)
- legislation.gov.uk: Human Medicines Regulations 2012, regulation C17 (guidelines on GMP and GDP)
- GOV.UK: Medicines: good manufacturing practice and good distribution practice
- GOV.UK: Sourcing medicines for the UK market
- GOV.UK: Acting as a Responsible Person (import)
- MHRA: GMDP database (licences and GMP/GDP certificates)
- EMA: Good distribution practice
- PIC/S: Aide-memoire: inspection of good distribution practice for medicinal products in the supply chain (PI 044-1, February 2023)
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Common questions
Does MHRA publish a GDP self-inspection checklist?
MHRA's GOV.UK guidance gives wholesalers a GDP compliance report to complete before a planned inspection, and the GDP guidelines require you to run your own self-inspection programme. This page turns every section of chapters 1 to 9 of the guidelines into checks you can run, in our words.
How often should a wholesaler self-inspect?
The guidelines ask for a programme that covers every part of GDP within a defined time frame, and don't set a frequency. You can split the programme into smaller self-inspections of limited scope, as long as together they cover everything within the time frame you set.
What counts as a critical GDP deficiency?
MHRA defines a critical GDP deficiency as any departure from good distribution practice that results in a significant risk to patients, including an activity that increases the risk of counterfeit medicines reaching patients. A major deficiency includes a major deviation from GDP or the terms of the wholesale licence, or the Responsible Person failing to fulfil their legal duties. Several "other" deficiencies together can add up to a major one.
Does it apply to pharmacies that hold a wholesale dealer's licence?
Yes. Every wholesale dealer's licence holder must follow the GDP guidelines, so a pharmacy that holds one follows them for its wholesale activity.
Does it work in Northern Ireland and the EU?
Yes. Licence holders in Northern Ireland follow the European Commission's GDP guidelines, and the 2013 text this checklist uses is still the Commission's current version. Where Great Britain and the EU differ, such as supplier databases and imports, the checks give both.
Or be ready whenever MHRA inspects
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