GMP gap review
Review the quality system and facility against the applicable standard, customer expectation, state rule, and product risk.
ILC helps production teams connect quality responsibilities, facilities, sanitation, people, materials, suppliers, equipment, records, deviations, complaints, and recalls before an audit or customer requirement exposes the gaps.

ILC works the way an auditor will: follow an actual product, person, piece of equipment, or quality event through the system and see whether the room and record support each other.
A prioritized quality-system gap list
Stronger batch and traceability records
Clear deviation and corrective-action practice
Staff prepared to explain the work during an audit
The exact engagement depends on your license, locations, stage, and internal capacity.
Review the quality system and facility against the applicable standard, customer expectation, state rule, and product risk.
Follow people, materials, equipment, sanitation, environmental controls, production, hold, release, and records through a live process.
Test deviations, nonconforming material, complaints, investigations, corrective action, supplier issues, and recalls.
Organize evidence, rehearse interviews and record retrieval, close priority findings, and assign remaining work.
Most problems show up when what staff do, what the system records, and what the written procedure says no longer match.
Production moves forward while records, holds, deviations, or specifications are completed later.
The log shows completion but no one defines what clean means or checks recurring failures.
Traceability is assumed until a practice exercise tries to reconcile the affected inventory and contacts.