Prepare for a GMP audit: a checklist for small teams

1. Establish which kind of examination is approaching

This guide addresses preparation in the EU GMP context of human medicinal product manufacturing. For GDP, medical devices or other activities, establish the appropriate basis and scope separately. The following terms describe different situations:

EU GMP Chapter 9 addresses self-inspections. It calls for a planned programme, competent and independent conduct, and records of observations and follow-up actions. EMA explains regulatory inspections separately. A successful customer audit does not replace an inspection by an authority.

2. Capture the actual state in one working sheet

Start with the invitation, agenda and agreed scope. Identify the sites, processes, products and systems included. During a regulatory inspection, your internal plan does not limit the authority’s powers. Prepare a route for directing additional questions to the appropriate responsible people.

Read previous reports alongside their follow-up actions. For each relevant finding, check whether the agreed change was implemented, where the evidence is held and whether the effectiveness check remains open. Include known changes since the last examination, such as new systems or different responsibilities.

Separate three states: present and traceable, present but requiring clarification, and genuinely missing. Evidence that is difficult to locate initially requires different work from an activity that was never performed. Describe the specific uncertainty in each open item. “Review documentation” is too broad; “establish the approval status of the latest system change” can be assigned and completed.

3. Prioritise open items by their potential impact

The following classification is our working aid for preparation. It is not a regulatory deficiency classification and does not replace your quality risk assessment. The responsible quality function assesses the technical implications.

Sorting by the oldest file date adds little value. Something discovered yesterday may need a decision first. Equally, time pressure does not justify retrospectively creating evidence that an activity was performed. Record the existing state truthfully and agree how missing information will be assessed.

Senior management decides which capacity is available and which other work can be deferred. EU GMP Chapter 1, section 1.5, establishes management responsibility for adequate resources and defined responsibilities.

4. Assign work with a defined completed result

Use one row for each open item. State what should be produced and who will assess it. This allows the quality lead to distribute work instead of doing every task while also chasing its status.

Use short working meetings for new information, decisions due and obstacles. Replace “nearly done” with an observable status, such as “distribution list reviewed, two confirmations pending”. Assign a deputy for questions. If the quality lead is absent, use the guide to GMP cover and handover arrangements.

Add useful project-specific fields while keeping the list manageable.

5. Walk through one completed activity

Select a completed activity within the examination scope, such as a system change. Ask the responsible colleague to explain what changed, who made the decisions and which evidence supports the result. Follow the path from the requirement through implementation to its documented outcome.

Record where retrieval stalls or explanations and documents do not agree. Check whether the deputy can access the information as well. This rehearsal examines the working process and evidence; it is not an exercise in memorising desirable answers.

For the actual meeting, identify contact people, subject experts and support for retrieving documents. Maintain a traceable record of requests and material supplied. Ask for clarification if a question is unclear. If information needs checking, say so and organise the follow-up. For conflicting document versions, use the GMP document control guide. Assign someone to track outstanding requests so they do not disappear between conversations.

6. Arrange follow-up work before the audit starts

Reserve capacity for the period after the examination. Record each finding with an accurate description, affected processes and the relevant requirement. Resolve questions about its meaning before proposing actions. Follow the response deadlines specified or agreed for that examination.

Distinguish immediate correction, addressing the cause and demonstrating effectiveness. Updating an SOP can be an action; it does not yet prove that the working process functions as intended. EU GMP Chapter 1, section 1.4(xiv), connects root-cause investigation, appropriate corrective or preventive actions and effectiveness assessment.

A few internal measures can support the next preparation cycle: items with unclear ownership, decisions due, missing evidence and completed effectiveness checks. Use them to plan capacity. They cannot guarantee an audit outcome. If preparation is already displacing daily operations, we can discuss a defined work package for audit preparation while operations continue. Start with the decision or evidence gap consuming the most attention.