Preparing for a TGA GMP Inspection: A Practical Guide

A TGA GMP inspection is one of the most consequential events in the lifecycle of a pharmaceutical manufacturer. Whether you are seeking a new licence, renewing an existing one, or facing a routine surveillance visit, the outcome directly affects your ability to supply medicines to the Australian market.

The good news: inspections are not designed to catch you out. They are designed to verify that your quality system is fit for purpose and that patients are protected. With structured preparation, most facilities can approach an inspection with genuine confidence.

TGA inspectors assess compliance against the Code of GMP for Human Blood and Blood Components, Human Tissues and Human Cellular Therapy Products or the PIC/S Guide to GMP, depending on your product type. They are not simply checking paperwork — they are evaluating whether your quality system is lived day-to-day.

Key focus areas include:

• Quality Management System (QMS): Is your QMS documented, understood, and consistently followed?
• Personnel: Are staff trained, competent, and aware of their GMP responsibilities?
• Premises and equipment: Are facilities maintained, qualified, and fit for purpose?
• Documentation: Are batch records, SOPs, and change controls complete, accurate, and retrievable?
• Production and process controls: Are critical process parameters defined and monitored?
• Quality control: Is your laboratory operating to validated methods with appropriate oversight?
• CAPA system: Are deviations and complaints investigated thoroughly and closed out effectively?

The single most valuable thing you can do before an inspection is an honest internal gap assessment. Map your current practices against the applicable GMP standard and identify where gaps exist.

Common gaps we see in Australian facilities include:

• SOPs that have not been reviewed within their defined review cycle
• Training records that are incomplete or not linked to specific procedures
• Equipment qualification documentation that is missing or out of date
• CAPA actions that have been raised but not closed within agreed timeframes
• Change control records that lack adequate impact assessments

Once gaps are identified, prioritise them by risk. Not every gap can be closed before an inspection, but demonstrating that you have identified issues and have a credible remediation plan is far better than an inspector discovering them first.

Documentation is the backbone of any GMP inspection. Inspectors will request records on the day — and the speed and accuracy with which you can produce them sends a strong signal about your quality culture.

Before the inspection:

• Ensure your document management system is current and all SOPs are at their correct revision
• Confirm that batch records for recent batches are complete and filed correctly
• Review your deviation and CAPA logs — close out any overdue items or document a justified extension
• Prepare a site master file (SMF) or product dossier if not already current
• Brief your document control team on how to retrieve records efficiently

An inspection is not just a quality department event. Production supervisors, laboratory analysts, warehouse staff, and maintenance personnel may all be interviewed. Brief your team on:

• What to expect during the inspection
• How to answer questions honestly and concisely (inspectors appreciate directness)
• Who to escalate to if they are unsure of an answer
• The importance of not volunteering information beyond what is asked

Role-playing common inspector questions in a mock inspection setting is one of the most effective preparation tools available.

A mock inspection conducted by an experienced external consultant provides an objective view of your readiness that internal teams often cannot achieve. A well-run mock inspection will:

• Simulate the inspection process from opening meeting to closing meeting
• Identify critical and major observations before the real event
• Give your team practice responding under pressure
• Produce a written report with prioritised remediation actions

At Vitalane, mock inspections are conducted by consultants with direct experience of TGA, FDA, and EU GMP inspections — with knowledge of what inspectors look for from both sides of the table.

When the inspection begins:

• Designate a single point of contact (usually the Quality Manager or Qualified Person) to accompany the inspector at all times
• Have a back-room team available to retrieve documents and answer technical questions
• Take contemporaneous notes of all observations raised
• Do not argue with observations during the inspection — note them and address them in your response

If observations are raised, your written response is your opportunity to demonstrate the strength of your quality system. A well-structured response will:

• Acknowledge each observation clearly
• Provide a root cause analysis
• Describe the corrective actions taken or planned
• Include evidence of implementation where possible
• Commit to realistic timeframes

A thoughtful, evidence-based response can significantly influence how TGA classifies an observation and whether follow-up action is required.

Inspection readiness is not a one-time exercise — it is a reflection of how well your quality system functions every day. Facilities that invest in ongoing compliance maintenance, regular internal audits, and a strong quality culture consistently perform better in inspections than those that scramble to prepare in the weeks before.

If you would like an independent assessment of your inspection readiness, contact Vitalane to discuss a gap assessment or mock inspection.