How to Prepare for Your First GMP+ Audit — Checklist
Michał Cierpiałowski, GMP+ Lead Auditor · · about 11 min read
This is a practical checklist for companies preparing for their first GMP+ certification audit. For the process itself, see our article on the GMP+ certification process; the full scope of requirements is covered on our GMP+ requirements page.
Why good preparation matters
A failed or drawn-out certification audit is more than stressful — it costs real money: billed time for a follow-up visit, staff time spent closing out non-conformities under pressure, and a delay before the company can point customers to its certificate. In extreme cases, serious findings can mean part of the audit has to be repeated, adding weeks to the process. Good preparation won't eliminate risk entirely — a first audit is demanding even for solidly prepared companies — but it cuts the chance of serious findings that are hard to fix. Preparing for an audit is really about putting in order a quality system that should already run day to day, not a one-off task done "for the audit".
Documentation — are your procedures current and actually followed
The first step is reviewing the whole system: procedures, work instructions, the quality policy. The key question isn't "do the documents exist" but "does what's written in them actually happen at the plant". This is a common problem auditors find during first audits — a procedure describes a process from two years ago, before the line or supplier changed, and nobody updated it. That gap between paper and reality signals that documentation isn't genuinely maintained, and it almost always leads to a non-conformity, even when the process itself runs correctly.
The practical check is simple: walk each key procedure through the plant and verify step by step whether it matches what staff actually do. If a procedure calls for an hourly temperature check, confirm the records back that up; if it describes batch marking, check the labels on the floor. The full scope of documentation requirements is covered on our GMP+ requirements page.
Records and registers — completeness and coverage of the required period
The second area is records — inspection logs, cleaning protocols, receipt and dispatch registers, pest-control records, calibration certificates. The auditor checks not just whether records exist, but whether they're complete and gap-free for the whole required period. A missing daily entry, an unmarked batch, or a skipped week in the cleaning schedule are typical, seemingly minor issues that add up and shape the auditor's picture of an inconsistently run system. Before the audit, sit down with the people responsible for each register and go through them entry by entry for the last few months, exactly as the auditor will — better to know about gaps in advance than be caught off guard.
HACCP analysis — does it reflect your current process and product range
The HACCP analysis dates fastest, since companies change their range, add raw materials or modify the line more often than they update risk documentation. Before the audit, check whether it reflects everything actually produced today, not just what was current when the document was written. If a new raw material, high-risk supplier or mixing technology has been introduced since, the hazard and critical control point analysis should reflect that, with updated control points and critical limits. Auditors typically cross-check the analysis against the current product range — a mismatch is a serious warning sign, since it touches the core of feed safety, not just paperwork.
Staff training — documentation alone isn't enough
Companies preparing for a first audit often focus on having a complete set of certificates and attendance sheets. That's necessary but not sufficient — the auditor talks directly to staff on the floor and asks about basic rules and procedures. If someone can't explain why they follow a procedure, or doesn't know where to find their own workstation's instruction, that tells the auditor training happened on paper without knowledge being transferred. A good practice is short, informal conversations with key staff beforehand — not an exam, just talking about what they do and why — to catch gaps before the auditor does. Training scope and format required by the standard is covered on our GMP+ training page.
Supplier review — current certificates and documentation
Another area to check is documentation for key suppliers — raw materials, transport, and firms handling the warehouse or pest control. Verify that certificates for suppliers covered by GMP+ or equivalent standards are still valid, and that your process for qualifying new suppliers is actually applied to every new relationship, not just described on paper. Companies that skip this review regularly discover, just before the audit, that a key supplier's certificate expired months earlier — a missing current document is easy to spot and hard to fix quickly.
Internal mock audit — why it's worth doing
One of the most valuable steps ahead of a first certification audit is running an internal mock audit. Someone who knows the standard well — a trained employee or an external advisor — goes through the plant and documentation exactly as the auditor will: checking procedures and records, talking to staff, walking the floor and warehouse. Its value lies in catching the same issues a real auditor would, while the company still has time to fix them without affecting the actual outcome. Companies that run a thorough mock audit a few weeks beforehand typically end up with far fewer non-conformities than those that skip this step.
Physical condition of the site — what the auditor looks at during the walk-through
Besides documentation, the auditor always walks the plant — often the most stressful part for companies going through it for the first time. They focus on cleanliness and order on the floor and in the warehouse, correct labelling of zones, raw materials and hazardous substances, the condition of equipment in contact with feed, and whether pest-control measures actually work, not just described on paper. A simple rule that helps is to walk the plant through an outsider's eyes. Things staff have grown used to and stopped noticing — a damaged door between zones, an unlabelled container, an open window near the line — are usually the first things an auditor spots.
Who from the company should be present during the audit
Plan in advance who will be available on audit day. As a rule you need a management representative for the quality system, who accompanies the auditor most of the day and answers questions on documentation and system-level decisions. It also helps to have people responsible for specific areas — production, warehouse, transport — on hand, since the auditor usually wants to talk to the people doing the work. Name one point of contact who coordinates the day and keeps the needed documents within easy reach.
What happens if non-conformities come up during the audit
Non-conformities during a first audit aren't the end of the world and don't automatically mean the certification has failed. GMP+ has a clear procedure for this — the company receives a report and must submit, by a set deadline, a corrective action plan (CAPA) that fixes the direct cause and prevents recurrence. Minor non-conformities usually just require implementing that plan by the deadline, with no repeat visit needed; more serious ones, especially those touching product safety, may call for a shorter verification visit. A thorough root-cause analysis with concrete actions makes a far better impression than trying to minimise a problem on paper.
The most common mistakes companies make preparing for their first audit
A handful of mistakes recur often enough to name directly: starting too late — two or three weeks out, with no time to genuinely close gaps, only to patch documents in a hurry, which auditors usually spot easily; treating training as a formality, a signed sheet with no real transfer of knowledge; skipping the mock audit, so systemic problems only surface during the real one; focusing solely on documentation while neglecting physical condition; and having no single person coordinating preparations, so tasks like reviewing supplier documentation end up assigned to no one.
The role of an advisor in audit preparation
For companies implementing GMP+ for the first time, an external advisor's experience is often valuable — they know the requirements from an auditor's perspective and can assess documentation and the plant without the "blind spots" people working there day to day naturally have. Their role usually includes reviewing documentation for compliance, running a mock audit, helping close gaps in the HACCP analysis and records, and preparing the team for the auditor's questions. It isn't a requirement for certification — an experienced internal team can prepare alone — but external support typically shortens preparation and reduces the risk of more serious non-conformities. A general overview of the standard is on our what is GMP+ page.
Summary
Preparing for a first GMP+ audit comes down to a practical review of five areas: documentation versus reality, complete records, an up-to-date HACCP analysis, staff's actual knowledge, and supplier documentation — then verifying it all with an internal mock audit before the certification body's auditor does. Non-conformities at a first audit are common and don't mean failure, as long as the company closes them out quickly with a CAPA plan. Good preparation — whether handled in-house or with an experienced advisor — genuinely improves the chances of a smooth audit and faster certification.
Glossary of terms
- Certification audit
- The first, full audit carried out by the certification body, a positive outcome of which leads to the issuing of a GMP+ certificate.
- Mock audit
- An internal simulation of the certification audit, carried out ahead of the auditor's visit to catch gaps in the system in advance.
- Non-conformity
- A deviation from the standard's requirements identified during a review of documentation or a plant inspection, requiring corrective action within a set deadline.
- CAPA
- A corrective and preventive action plan submitted by the company in response to identified non-conformities.
- HACCP analysis
- An analysis of hazards and critical control points in the production process, forming the basis of the feed safety system required by GMP+.
- Supplier qualification
- The process of verifying a supplier of raw materials or services against its certificates and compliance with the company's quality system requirements.
Related pages
Learn about the certification process and the standard's requirements.
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