Know Your Gaps Before the Inspector Does
A thorough pre-inspection evaluation identifies documentation weaknesses, process deviations, and compliance gaps — giving your team time to correct them before a regulatory visit.
What Is a GMP Pre-Inspection?
A GMP pre-inspection is a structured, expert-led evaluation of your facility, documentation, and processes against the regulatory standards your inspectors will apply.
Conducted by consultants with direct experience as former regulatory inspectors, our pre-inspection service mirrors the actual inspection process — so you see exactly what an authority would see.
The result is a prioritised gap report with actionable corrective recommendations, giving your team a clear roadmap to close findings before they become official observations.
What We Evaluate
Our pre-inspection covers every area a regulatory inspector would examine, tailored to your facility type and target markets.
Quality Management System
SOPs, change control, deviation management, CAPA effectiveness, and management review processes.
Documentation & Records
Batch records, logbooks, validation protocols, and data integrity across paper and electronic systems.
Production & Process Controls
Manufacturing procedures, in-process controls, equipment qualification, and cleaning validation.
Laboratory Controls
Analytical methods, OOS/OOT investigations, stability programmes, and laboratory data integrity.
Facilities & Equipment
Environmental monitoring, HVAC qualification, calibration programmes, and maintenance records.
Supplier & Material Controls
Approved supplier lists, incoming material testing, and supplier audit programmes.
How the Pre-Inspection Works
A structured four-phase process that mirrors a real regulatory inspection from opening meeting to final report.
Scoping & Planning
We review your regulatory targets, product portfolio, and recent inspection history to tailor the evaluation scope and focus areas.
Document Review
Key quality documents, SOPs, batch records, and validation files are reviewed against applicable GMP standards before the on-site visit.
On-Site Facility Evaluation
Our consultants conduct a systematic walkthrough of production areas, laboratories, warehouses, and utilities — asking the questions an inspector would ask.
Gap Report & Recommendations
A prioritised written report details every finding, its regulatory basis, and a practical corrective action recommendation with suggested timelines.
What You Receive
Prioritised Gap Report
Every finding classified by risk level (critical, major, minor) with the specific GMP clause or guideline it relates to.
Corrective Action Roadmap
Practical, implementable recommendations for each gap — not just what is wrong, but how to fix it.
Inspection Readiness Score
An overall readiness assessment across key GMP chapters, giving management a clear picture of current compliance status.
Follow-Up Support
Optional follow-up sessions to review CAPA implementation progress and verify closure of critical findings.
Regulatory Standards We Cover
Our consultants are experienced with the major GMP frameworks applied across CIS and international markets.
Ready to Find Your Gaps Before the Inspector Does?
Our pre-inspection service gives you the clarity and time to address compliance gaps on your own terms — not under regulatory pressure.