What Chapter 8 actually requires
Self-inspections must be conducted to monitor implementation of and compliance with GDP principles, and to propose necessary corrective measures. They must be performed at appropriate regular intervals following a prearranged programme, and records must be made. The RP is responsible for ensuring this happens and that corrective measures are put in place.
Two words in that requirement carry most of the weight. “Prearranged” means the programme exists before the inspections, not reconstructed afterwards. “Regular intervals” means the frequency is defined and justified, and then actually met.
Scoping the programme across the chapters
A programme that inspects everything once a year in a single pass tends to be shallow. A more defensible structure covers the GDP chapters across a rolling cycle, weighted by risk, so that higher-risk areas are visited more often.
A workable rolling scope
- Quality management: change control, deviations, CAPA effectiveness, management review.
- Personnel: RP arrangements, training records, competence for delegated tasks.
- Premises and equipment: temperature mapping currency, calibration, pest control, security.
- Documentation: version control, record retention, data integrity.
- Operations: supplier and customer qualification, receipt checks, picking accuracy, expiry control.
- Complaints, returns, falsified products and recalls: including a recall test.
- Outsourced activities: contracts, audits of providers, performance monitoring.
- Transportation: route risk, packing validation, third-party carrier oversight.
Independence
Self-inspections should be conducted in an independent and detailed way by designated competent persons. A manager auditing their own area is the most frequent structural weakness, because it makes an adverse finding personally costly to raise.
Small organisations cannot always achieve full independence internally. Where they cannot, the usual mitigations are cross-auditing between functions, using the RP for areas outside their direct management, or bringing in an external auditor for the higher-risk chapters.
Findings and closure
A finding needs a description specific enough to be verifiable, a cause rather than a restatement of the symptom, an owner, a due date, and evidence of completion. The step most often missing is effectiveness review: confirming some months later that the corrective action actually held.
Where the same finding recurs across cycles, the CAPA was addressing a symptom. Recurring findings with closed CAPAs are worse than open findings, because they show the closure process is not working.
Using self-inspection as inspection preparation
The most useful property of a good self-inspection programme is that it makes an MHRA inspection unremarkable. If your last two cycles are complete, findings are closed and effectiveness has been reviewed, the inspector is largely reading a record you already maintain.
The inverse is also true: an inspector who finds the self-inspection programme incomplete will generally widen the inspection, because the organisation has not demonstrated it can find its own problems.
Common questions
- How often should self-inspections be carried out?
- GDP requires appropriate regular intervals rather than a fixed period. Annual full coverage is common, often delivered as a rolling programme with higher-risk areas revisited more frequently. The frequency should be justified and documented.
- Can the RP carry out the self-inspections?
- Yes, and in smaller organisations the RP often does. The constraint is independence: the RP should not be the sole auditor of areas they directly manage day to day.
- Do self-inspection records need to be shown to MHRA?
- Inspectors routinely ask to see the programme, recent reports and the CAPA status. Records should be retained and retrievable.
Sources
- Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use 2013/C 343/01
- MHRA — Medicines: good manufacturing practice and good distribution practice
- MHRA Guidance Note 6 — applicants and holders of a Wholesale Dealer’s Licence or Broker Registration Fifth edition 2022, section 9 amended 2023