An inspection is a demonstration, not an exam
Most sites do not fail on compliance. They fail on retrieval speed, on inconsistent accounts of the same process, and on commitments from last time that were closed on paper but never evidenced. These three guides cover what to do before, during and after.
The controls are usually already there. What decides the first day is whether you can show them at inspection pace — and that is a rehearsal problem, not a compliance one.
Where to start depends on your date
Preparing for a GMP inspection
Preparation is mostly about demonstrability rather than compliance: the controls are usually already there, and what decides the first day is whether you can show them at inspection pace.
- What should you prepare?
- What documents should be available?
- What should management know?
- What should QA review?
During a GMP inspection
The inspection is a sampling exercise: what the inspector finds early determines how deep they go, so the first hours carry disproportionate weight.
- How inspections work
- What inspectors may ask
- How employees should respond
- Common organisational mistakes
After a GMP inspection
The response letter is a set of commitments to a regulator on a fixed deadline — and over-committing converts a quality problem into a missed regulatory commitment, which is worse.
- Handling observations
- Root-cause analysis
- CAPA
- Remediation
- Management oversight
The requirements behind the guides
A rehearsal is the cheap place to find the gap
Timed retrieval, back-room simulation, SME questioning and narrative consistency across departments, run at inspection pace. It takes less than a day to learn how the first day would go.