An FDA or TGA inspection is not something you prepare for in the weeks before the inspector arrives. By then, the preparation is either done or it isn't. Inspection readiness is an ongoing state — built through consistent quality practices, well-maintained documentation, and a team that understands what regulators are looking for.
That said, a structured pre-inspection review can surface gaps that are still fixable, and it focuses attention on the areas most likely to draw scrutiny.
Documentation
Regulators inspect documentation intensively. Common findings relate to incomplete or inconsistent batch records, SOPs that are out of date or not followed in practice, change controls that lack adequate impact assessment, CAPA records that are open too long or lack effectiveness checks, and laboratory raw data that does not support the final results.
Run a documentation audit before the inspection. Check that SOPs reflect current practice, batch records are complete, and CAPA actions are closed with evidence.
Quality systems
Inspectors assess whether your quality system is functioning, not just whether it exists on paper. Key areas include management review engagement with quality data, internal audits conducted on schedule with findings acted on, supplier qualification and monitoring, and OOS results properly investigated and closed.
People
Inspectors interview staff. The most common source of inspection findings is not missing documentation — it is employees who cannot explain the procedures they are supposed to follow. Ensure all staff have current training records, supervisors can walk inspectors through any relevant process clearly, and there is a designated back-room team to gather requested documents quickly.
How TPC can help
We provide pre-inspection audits and inspection readiness programmes for both FDA and TGA inspections. We also support sponsors in preparing responses and CAPA after an inspection. Contact us to discuss your situation.