How to read this list
The number of documents matters far less than the coverage. A site with fifteen well-used procedures is in a better position than one with sixty that staff cannot find. Combine where activities are genuinely related, and split where a single document would need to serve two different audiences.
The mapping to chapters below is useful for a different reason: it is the structure an inspector uses, so a documentation set organised this way is easier to demonstrate against.
Quality system and documentation
- Quality manual or quality policy defining the system and responsibilities.
- Document control: creation, review, approval, versioning, withdrawal.
- Record retention and archiving, including data integrity expectations.
- Change control.
- Deviation and CAPA management.
- Self-inspection programme and reporting.
- Management review.
- Quality risk management.
Personnel and premises
- RP duties, delegation and deputising arrangements.
- Training: induction, role-specific, refresher, competence assessment.
- Hygiene and personnel practices where relevant to the operation.
- Premises security and access control.
- Temperature mapping and monitoring, including alarm response.
- Equipment calibration and maintenance.
- Cleaning and pest control.
Operations
- Qualification and ongoing review of suppliers.
- Qualification and ongoing review of customers, including bona fide checks.
- Receipt of goods and incoming checks.
- Storage, segregation and stock rotation.
- Expiry and short-dated stock control.
- Picking, checking and despatch.
- Order processing and supply to permitted recipient categories.
- Export and, where applicable, import arrangements.
Complaints, returns, falsified products and recalls
- Complaint handling.
- Returns assessment and disposition, including return to saleable stock.
- Suspected falsified medicinal products.
- Recall management, including recall testing.
- Destruction of unusable stock.
- Reporting to MHRA and to marketing authorisation holders.
Outsourcing and transport
- Selection, contracting and audit of outsourced activity providers.
- Transport and delivery, including vehicle and container controls.
- Packing for temperature-sensitive shipments and validation of shipper configurations.
- Handling of deliveries that cannot be completed.
Where controlled drugs are involved
Controlled drugs add a separate layer that sits alongside GDP rather than inside it: Home Office licensing, safe custody, record keeping under the Misuse of Drugs Regulations, destruction witnessing, and transport security. The Home Office publishes SOP guidelines specifically for licensees, and these are worth reading against your existing set rather than assuming GDP procedures cover them.
Common questions
- Is there an official list of required GDP SOPs?
- No. GDP describes activities that must be governed by written procedures, and the required set follows from the activities your licence covers. Two sites with different scopes will legitimately hold different documentation sets.
- How often should SOPs be reviewed?
- Your document control procedure should define a review period and it should be met. Periodic review is also the natural point to check that the procedure still matches what staff actually do.
- Can we adopt a template SOP set?
- Templates are a reasonable starting point but become a liability if adopted unchanged. Inspectors compare the procedure to the observed practice, and a template describing a process you do not follow is worse than a shorter procedure that is accurate.
Sources
- Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use 2013/C 343/01
- MHRA Guidance Note 6 — applicants and holders of a Wholesale Dealer’s Licence or Broker Registration Fifth edition 2022, section 9 amended 2023
- Home Office — Controlled drugs: standard operating procedure guidelines