Are You Really Ready for Your Next GMP Inspection?
Many sites think they're ready — until the inspectors are already in the building.
A GMP inspection tests whether your product, processes, systems and facilities, all documented in the PQS, holds up under questioning — whether your validation records, your software data integrity controls and your team's answers all tell the same consistent story an inspector can follow. Most pharmaceutical manufacturers find out the hard way that "we have a system" and "our system is inspection-ready" are two different things.
The gap usually isn't one big failure. It's a build-up of smaller ones — a deviation closed without full root cause, a training system that's technically compliant but wouldn't survive a deep dive, a process validation that works only within a narrow range of a critical process parameter. Collectively and individually, the difference between a clean GMP inspection with some findings versus a site sitting on a list of critical observations.
The GMP Pharmaceutical Regulatory Inspection Readiness Scorecard is a free, 20-question self-assessment built against the PIC/S PE009-17 GMP guide — the same standard inspectors work from. It's designed to surface exactly the kind of gaps that show up in an inspection, before an inspector finds them.
What You'll Learn
Whether your genuinely inspection-ready, or showing the kind of fatigue that flags an inspector's attention
Whether your validation and data-integrity programs would withstand scrutiny
Whether your team's inspection behaviour — how they answer, how they navigate the PQS live — helps or harms your audit outcome
Where to focus next before your inspection, ranked by what actually drives inspection findings
Who Is This Scorecard For?
Pharmaceutical manufacturers with a GMP licence, preparing for a routine or triggered inspection
Sites that haven't been inspected recently and want an honest external self-review
Quality, validation and production leads responsible for the site's inspection outcome
Growing manufacturers without a dedicated, full-time GMP compliance resource
Why This Scorecard, Why QSN?
QSN works with GMP pharmaceutical manufacturers for a living, they are our core 'bread & butter' — this scorecard is built from that experience, not a generic compliance checklist repurposed for pharma.
QSN's approach is phase-appropriate: right-sized for where your site actually is, not an enterprise-scale system bolted onto a growing manufacturer. The scorecard reflects that — it flags what matters for a site your size, not everything a Fortune 500 GMP site would need.
What Happens After You Complete It?
You'll see how your site tracks against PIC/S PE009-17 across QMS, validation, production, data integrity and team readiness. We'll send you followup emails to see how you got on. If you want assistance or a recommended next step — from a targeted fix through to a full pre-inspection audit ahead of your next TGA visit - then please book a call with us.
