GDP guide · Sources checked October 2026
GDP documentation requirements for wholesalers
GDP documentation requirements for wholesale distributors are set out in Chapter 4 of the EU Good Distribution Practice guidelines (2013/C 343/01): written procedures and records that are approved, dated, readily retrievable and kept for at least five years, with a record made at the time of every transaction in medicinal products. MHRA Guidance Note 6, section 8.1, says wholesale dealer’s licence holders must comply with the conditions in regulations 43 to 45AB of the Human Medicines Regulations 2012, including Good Distribution Practice.
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GDP record keeping requirements
What the guidelines say about records
These are the Chapter 4 rules, plus the licence condition on supply records. Check the linked text for the full wording.
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| Topic | What the guideline or guidance says | Source |
|---|---|---|
| What counts as documentation | All written procedures, instructions, contracts, records and data, on paper or electronic, which should be readily available and retrievable | EU GDP guidelines, section 4.2, checked October 2026 |
| Transaction records | Kept for every medicinal product received, supplied or brokered, with at least the date, product name, quantity, supplier or customer name and address, and the batch number for products bearing safety features | EU GDP guidelines, section 4.2, checked October 2026 |
| Made at the time, and corrections | Records should be made at the time each operation is undertaken. Any alteration should be signed and dated and still let the original be read | EU GDP guidelines, section 4.2, checked October 2026 |
| Retention | Documents are retained for the period in national legislation but at least five years. Personal data should be deleted or anonymised once no longer needed for distribution activities | EU GDP guidelines, section 4.2, checked October 2026 |
| Supply records for retail customers | A licence holder supplying someone who may lawfully sell by retail keeps a record of the supply for a minimum of five years and keeps it available to the MHRA for inspection | MHRA Guidance Note 6, Appendix 2, checked October 2026 |
| Computerised system data | Back-up data retained for the period in national legislation but at least five years, at a separate and secure location | EU GDP guidelines, section 3.3.1, 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 SOP requirements
Procedures, version control and who approves them
The guidelines do not list which SOPs a wholesaler needs. They set how procedures are controlled, and say all key operations should be described in the quality system.
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| Topic | What the guideline says | Source |
|---|---|---|
| Approval | Procedures should be approved, signed and dated by the Responsible Person; other documents by appropriate authorised persons | EU GDP guidelines, section 4.2, checked October 2026 |
| Version control | Documents should be reviewed regularly and kept up to date, with version control, a system to prevent use of a superseded version, and obsolete procedures removed from workstations and archived | EU GDP guidelines, section 4.2, checked October 2026 |
| Quality manual | A quality manual or equivalent documentation approach should be established, and the quality system fully documented | EU GDP guidelines, section 1.2, checked October 2026 |
| Access for staff | Each employee should have ready access to the documentation needed for their tasks | EU GDP guidelines, section 4.2, 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 training requirements
Training records for wholesale staff
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| Topic | What the guideline says | Source |
|---|---|---|
| Who is trained | All personnel involved in wholesale distribution should be trained on GDP and have appropriate competence and experience before starting their tasks | EU GDP guidelines, section 2.4, checked October 2026 |
| Programme and records | Initial and continuing training based on written procedures and a written training programme; a record of all training is kept and its effectiveness periodically assessed and documented | EU GDP guidelines, section 2.4, checked October 2026 |
| Special handling | Staff handling products with stricter conditions, including temperature-sensitive products, receive specific training | EU GDP guidelines, section 2.4, checked October 2026 |
| Job descriptions | An organisation chart, and written job descriptions for key positions with deputising arrangements | EU GDP guidelines, section 2.3, 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 supplier qualification records
Supplier and customer qualification
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| Topic | What the guideline says | Source |
|---|---|---|
| Suppliers | Supplies must come only from holders of a wholesale distribution authorisation or a manufacturing authorisation covering the product. Qualification and approval should be done before procurement, controlled by a procedure, documented and periodically rechecked | EU GDP guidelines, section 5.2, checked October 2026 |
| Customers | Supply only to holders of a wholesale distribution authorisation or persons authorised or entitled to supply the public. Checks and rechecks may include copies of authorisations or verifying status on an authority website | EU GDP guidelines, section 5.3, checked October 2026 |
| Outsourced activities | Assess the contract acceptor’s suitability and authorisation status, define responsibilities in writing, and monitor and review their performance | EU GDP guidelines, section 1.3, 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.
Pharmaceutical wholesale compliance requirements
Records an inspector may expect to see
New applicants are told what to have ready; existing licence holders can use the same list as a self-check. See also the GDP inspection checklist.
Source: MHRA Guidance Note 6, section 7.1, checked October 2026. For the Responsible Person’s own duties, read wholesale dealer licence records.
- An approved quality management system including the quality manual, policies, SOPs and forms.
- A list of the risk assessments carried out.
- Training records and job descriptions for everyone involved, especially the Responsible Person.
- Evidence of a temperature mapping exercise of the wholesale area, with a clear method.
- A list of qualified suppliers and customers.
- A schedule and method for self-inspections.
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FAQ
Common questions
How long must GDP records be kept?
The EU GDP guidelines say documents should be kept for the period in national legislation but at least five years. MHRA Guidance Note 6 sets a minimum of five years for the record of supplies to retail customers. Ask your Responsible Person whether any record needs longer.
Can GDP records be electronic?
Yes. The guidelines define documentation as written procedures, records and data in paper or electronic form. Computerised systems should be validated or verified and data protected and backed up.
Does GDP list the SOPs I must have?
No list is given. The guidelines say all key operations should be fully described in the quality system, and set how procedures are approved and controlled.
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