GDP guide · Sources checked October 2026
GDP inspection checklist for UK wholesalers
A GDP inspection checklist lists the records and procedures a wholesale dealer should check against the Good Distribution Practice guidelines before the MHRA inspects, and the guidelines themselves require a recorded self-inspection programme covering all aspects of GDP. The MHRA inspects wholesale sites on a risk basis, and a successful inspection leads to a GDP certificate for each inspected site.
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MHRA GDP inspection checklist: how an inspection runs
What happens before, during and after an MHRA GDP inspection
The steps below are as GOV.UK describes them. The detail of your own inspection is for the MHRA inspector and your Responsible Person.
On smaller screens, scroll the table sideways to see every column.
| Stage | What the MHRA says | Source |
|---|---|---|
| Who is inspected, and when | Wholesale sites are inspected on a risk basis, and when a business applies for a licence. A GDP risk score depends on the activities on site and the deficiencies found, and indicates the likely date of the next inspection | GOV.UK: GMP and GDP, checked October 2026 |
| Before the inspection | A GDP compliance report must be completed before an inspection, unless the inspection is triggered, in which case notice is short or absent | GOV.UK: GMP and GDP, checked October 2026 |
| How deficiencies are graded | Critical, major and other. A critical deficiency is any departure from GDP that results in a significant risk to patients | GOV.UK: GMP and GDP, checked October 2026 |
| After the closing meeting | You receive a letter listing deficiencies and reply by email with corrective actions and dates. If the inspector accepts the reply, a GDP certificate follows with the inspection report; an unacceptable reply may lead to compliance escalation | GOV.UK: GMP and GDP, checked October 2026 |
| New applicants | Applicants are expected to be inspection ready when they apply, with items such as a quality management system, risk assessments, training records, a temperature mapping exercise, a list of qualified suppliers and customers, and a self-inspection schedule | MHRA Guidance Note 6, section 7.1, checked October 2026 |
Sources checked October 2026. Legislation and guidance change: open the linked source before relying on any row. This page is general information, not legal or regulatory advice; your Responsible Person and the MHRA decide what applies to your licence.
GDP self inspection checklist
A GDP audit checklist, chapter by chapter
Built from the headings of the EU GDP guidelines. The guidelines do not set a template, so these checks are a practical reading, not a legal test.
Sources checked October 2026. For what each record should hold, read GDP documentation requirements.
- Quality system: documented, with a Responsible Person appointed, change control in place, and deviations documented and investigated with CAPA (Chapter 1).
- Personnel: organisation chart, written job descriptions, a written training programme and training records, including the Responsible Person’s own GDP training (Chapter 2).
- Premises and equipment: temperature mapping, calibrated monitoring equipment, alarms for excursions, and maintenance and calibration records (Chapter 3).
- Documentation: approved, dated, version-controlled procedures, transaction records made at the time, and records kept for at least five years (Chapter 4).
- Operations: suppliers and customers qualified before trading, with the checks recorded and periodically repeated (Chapter 5).
- Complaints, returns, falsified medicines and recalls: procedures followed and recorded (Chapter 6).
- Outsourced activities: written contracts and review of contract acceptors (Chapter 7).
- Self-inspection: a programme, recorded reports, and CAPA documented and followed up (Chapter 8).
- Transport: temperature risk assessment of routes, calibrated transport monitoring equipment and a procedure for excursions (Chapter 9).
GDP inspection findings
GDP inspection findings the MHRA has published
The MHRA published GDP deficiency data for 2016 so that wholesalers could use it in self-inspection. It reviewed major findings in a sample of 148 of 1,428 inspections, so it shows examples, not a ranking. Newer data was not found on the pages we checked.
On smaller screens, scroll the table sideways to see every column.
| Area | Example of a major finding (paraphrased) | Source |
|---|---|---|
| Quality system | A deviation had been signed off as closed while CAPA actions were still outstanding; management review did not cover deviation analysis | MHRA GDP deficiency data 2016, checked October 2026 |
| Temperature | Cold chain temperature deviations were recorded but not taken through CAPA; temperature mapping had not been adequately done to place thermometers | MHRA GDP deficiency data 2016, checked October 2026 |
| Documentation | Gaps in contemporaneous temperature records, unsigned temperature records and unapproved corrections | MHRA GDP deficiency data 2016, checked October 2026 |
| Suppliers and customers | Supplier qualification did not include verifying the supplier’s GDP status; the customer qualification procedure did not cover all customer types | MHRA GDP deficiency data 2016, checked October 2026 |
| Self-inspection | Self-inspection not done at the frequency in the company procedure, and one branch left out of the schedule | MHRA GDP deficiency data 2016, checked October 2026 |
The MHRA advises against focusing on listed deficiencies at the expense of risks that are higher for your own organisation. Sources checked October 2026. Legislation and guidance change: open the linked source before relying on any row. This page is general information, not legal or regulatory advice; your Responsible Person and the MHRA decide what applies to your licence.
GDP inspection preparation: worked example (fictional)
Preparing for an inspection in one quarter
A fictional wholesaler, for illustration only. It is not advice on what your licence needs.
1
Fix the scope
Example Medicines Wholesale Ltd, a fictional business, lists every site, activity and outsourced service on its licence, and checks the quality manual describes each one.
2
Run a self-inspection by chapter
The Responsible Person, or a designated colleague, works through the chapter checklist above and records every observation in a dated report.
3
Sample the records
The team pulls ten recent supplier approvals, a month of temperature logs, three closed deviations and the training file for each member of staff, and checks each is complete, signed and retrievable.
4
Open CAPA for each gap
Each gap gets an owner, a due date and a root cause. The Responsible Person reviews the list and closes an item only when the action is done.
5
Brief the team
Staff are reminded where records are kept and that they should answer from the procedure, not from memory.
After the checklist
Where to read next
A checklist is only as good as the records behind it.
Read what the guidelines say about GDP documentation, how to keep deviation and CAPA records and how to record temperature excursions. If you are choosing a tool, see GDP compliance software compared.
GDP record tracking is not available yet
Soteriaa is building GDP record tracking; join the waitlist. It is not available yet, and it will not replace the Responsible Person or approve any record. Join the GDP waitlist to hear when it opens.
FAQ
Common questions
What does the MHRA check in a GDP inspection?
MHRA inspectors assess a wholesale site against Good Distribution Practice and the conditions of its licence, and grade deficiencies as critical, major or other. GOV.UK describes the process; the detail of any inspection is for the inspector.
Is a GDP self-inspection required?
Yes. Chapter 8 of the EU GDP guidelines says a self-inspection programme should cover all aspects of GDP, be recorded, and that corrective and preventive actions should be documented and followed up. MHRA Guidance Note 6 lists self-inspections among the Responsible Person’s responsibilities.
Is there an official GDP inspection checklist?
Not one that this page found. The MHRA asks for a GDP compliance report before an inspection, and publishes guidance and deficiency data. The checklist above is a practical reading of the guidelines, not an MHRA form.
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