Start from the last inspection
The first thing an inspector is likely to review is what was found last time and whether it was fixed. Open or superficially closed commitments from a previous inspection are the fastest route to an escalated outcome, because they raise a question about the organisation rather than about a process.
Before anything else, reconcile the previous findings against evidence of closure and effectiveness. Anything that cannot be evidenced should be treated as still open and addressed on that basis rather than presented as complete.
The records to have retrievable
Inspectors work from evidence, and the practical test is how long it takes to produce a specific record. Aim for minutes, not hours.
- Current licence, site master file or equivalent, and organisation chart.
- RP details, delegation records and deputising arrangements.
- Self-inspection programme, recent reports and CAPA status.
- Deviation and CAPA log with open items and due dates.
- Change control log.
- Training matrix and records for named individuals.
- Temperature mapping reports and current monitoring data, with calibration certificates.
- Approved supplier and customer lists with the evidence supporting approval.
- Recall procedure and the last recall test with its results.
- Complaints log and returns records including RP dispositions.
- Outsourced activity contracts and provider audit records.
The traceability walk
A common inspection technique is to select a batch and follow it end to end: purchase order, supplier qualification, receipt check, storage location and conditions, picking record, despatch documentation, customer qualification, and any returns. Gaps become obvious quickly because each step should reference the next.
Running this exercise yourself on two or three randomly chosen batches is the single most useful piece of preparation. It tests the system the way the inspector will, and it surfaces the breaks that a chapter-by-chapter document review does not.
Weaknesses that most often become findings
- Supplier and customer qualification performed at onboarding and never refreshed.
- Temperature mapping that predates a change in racking, stock profile or equipment.
- Training records that show attendance but not competence.
- CAPAs closed without effectiveness review, alongside recurring events.
- Recall procedures that have never been tested.
- Outsourced providers used without a current contract defining GDP responsibilities.
- Procedures that describe a process the site no longer follows.
During the inspection
Answer what is asked. Volunteering adjacent information tends to open new lines of enquiry without improving the outcome. Where you do not know, say so and undertake to find out rather than speculating — an inaccurate answer discovered later is more damaging than an acknowledged gap.
Keep your own record of what was requested, what was provided and what was discussed. It makes the response to the report substantially easier to write.
After the report
Responses should address root cause rather than restate the finding, give realistic dates, and distinguish completed actions from planned ones. Committing to a date you miss converts a resolved finding into a credibility problem at the next inspection.
Common questions
- How much notice is given for a GDP inspection?
- Routine inspections are normally notified in advance, but MHRA can inspect unannounced. A quality system that depends on a preparation period is fragile by design.
- What is the difference between critical, major and other deficiencies?
- They reflect risk to product quality and patient safety, and the classification drives the required response and timescale. Critical findings can affect the licence.
- Should the RP be present throughout?
- The RP is normally central to the inspection and should be available. Their inability to answer questions on their own duties is itself a finding.
Sources
- MHRA — Medicines: good manufacturing practice and good distribution practice
- 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