A GMP inspection by EU regulatory authorities is not a surprise visit. Inspectors announce themselves, provide an agenda, and follow a structured assessment process. What surprises manufacturers — particularly those being inspected for the first time — is the depth of the assessment and the specific areas where inspectors consistently find deficiencies.

Understanding what EU GMP inspectors look for, and preparing systematically for those areas, is the difference between an inspection that results in a compliance certificate and one that results in a critical finding that halts your EU market access.

What Is a GMP Audit in the EU Context?

Good Manufacturing Practice (GMP) inspections in the EU are conducted by national competent authorities — ANSM in France, BfArM/PEI in Germany, MHRA in the UK (post-Brexit, for UK market access), and equivalent bodies in other member states. EMA coordinates GMP inspections for products under the centralised procedure.

EU GMP requirements for pharmaceutical products are set out in EudraLex Volume 4 — the EU Guidelines for Good Manufacturing Practice for Medicinal Products. The guidelines consist of:

Part I: Basic requirements for medicinal products
Part II: Basic requirements for active substances used as starting materials
Part III: GMP-related documents (ICH guidelines, etc.)
Annexes: Specific requirements for sterile products, biologicals, radiopharmaceuticals, computerised systems, and other specialised areas

For cosmetic GMP, the relevant standard is ISO 22716 (not EudraLex). For food supplement GMP, food safety regulations apply. This article focuses on pharmaceutical GMP under EudraLex Volume 4.

When Does an EU GMP Inspection Occur?

EU GMP inspections are triggered by several circumstances:

Pre-approval inspection: Before a marketing authorisation is granted for a new product, EMA or the relevant national authority may inspect the manufacturing site to verify that it operates in compliance with GMP as described in the CTD dossier.

Routine surveillance inspection: Authorised manufacturing sites are subject to periodic routine inspections — typically every 2 to 3 years for active sites. The frequency depends on the site’s risk profile and inspection history.

For-cause inspection: Triggered by a specific concern — a product recall, a serious adverse event, a complaint from a competent authority in another country, or information suggesting non-compliance.

Import inspection: Sites outside the EU that manufacture products for the EU market may be inspected by EU authorities. These inspections are increasingly common for sites in the USA, India, China, and other major manufacturing countries.

What Do EU GMP Inspectors Examine?

EU GMP inspections follow a structured programme. Inspectors typically spend 2 to 5 days at a manufacturing site, depending on its complexity. The inspection covers:

Quality Management System

Inspectors review the overall quality management system — the quality manual, quality policy, organisational structure, and management review process. They look for evidence that quality is genuinely embedded in the organisation, not just documented on paper.

Common findings: Quality management reviews that are held but not acted upon; quality metrics that are tracked but not used for decision-making; quality systems that exist in documents but are not reflected in actual practice.

Personnel

Inspectors review personnel records for all staff involved in GMP activities — education, training, experience, and competence assessments. They conduct interviews with production and QC staff to assess their understanding of GMP requirements and their specific procedures.

Common findings: Training records that document attendance but not competence; staff who cannot explain the procedures they follow; inadequate training for new procedures or equipment.

Premises and Equipment

Inspectors walk the facility, assessing cleanliness, organisation, and control of the manufacturing environment. They review equipment qualification records (IQ, OQ, PQ) and maintenance and calibration records.

Common findings: Equipment used without current calibration certificates; qualification records that are incomplete or not reviewed after equipment modifications; environmental monitoring data that shows out-of-limit results without investigation.

Documentation

Documentation is the foundation of GMP compliance. Inspectors review batch manufacturing records, standard operating procedures, change control records, deviation records, and CAPA (corrective and preventive action) records.

Common findings: Batch records with missing entries, corrections made without explanation, or entries made after the fact; SOPs that are not followed in practice; change control records that don’t capture all changes; CAPA records where root cause analysis is superficial.

Production

Inspectors observe production activities in progress where possible. They review batch records for recently manufactured batches, in-process control data, and yield calculations.

Common findings: In-process controls not performed at the specified frequency; yield calculations that don’t match batch record quantities; production deviations that are not recorded or investigated.

Quality Control

Inspectors review QC laboratory practices — sample management, testing procedures, out-of-specification (OOS) investigation procedures, and stability testing programmes.

Common findings: OOS results that are invalidated without adequate investigation; stability samples stored under incorrect conditions; reference standards used beyond their expiry date; laboratory instruments used without current calibration.

Outsourced Activities

Where manufacturing steps are outsourced to contract manufacturers or contract testing laboratories, inspectors review the qualification of those contractors and the written contracts defining responsibilities.

Common findings: Contract laboratories used without qualification audits; written contracts that don’t clearly define GMP responsibilities; no oversight of contractor performance.

Complaints and Recalls

Inspectors review complaint handling procedures and records, and recall procedures. They look for evidence that complaints are investigated thoroughly and that systemic issues are identified and addressed.

Common findings: Complaints that are closed without adequate investigation; no trending of complaint data to identify systemic issues; recall procedures that have never been tested.

Critical, Major, and Minor Findings

EU GMP inspectors classify findings into three categories:

Critical deficiency: A deficiency that has produced, or leads to a significant risk of producing, a product that is harmful to the human or animal patient. Critical findings result in immediate action — typically suspension of the manufacturing authorisation or refusal of import.

Major deficiency: A non-critical deficiency that indicates a major deviation from GMP requirements; a deficiency that may produce a product that does not comply with its marketing authorisation; or a combination of several “other” deficiencies that together represent a major deficiency. Major findings require a corrective action plan within a defined timeframe (typically 30 to 90 days).

Other (minor) deficiency: A deficiency that cannot be classified as either critical or major but indicates a departure from GMP. Minor findings require a corrective action plan but typically allow continued operation.

How to Prepare for an EU GMP Inspection

12 Months Before

Conduct a full internal GMP audit against EudraLex Volume 4
Address all findings from the internal audit
Review and update all SOPs — particularly those for areas with historical findings
Ensure all equipment qualification and calibration records are current
Verify that the stability testing programme is on track and results are within specification

3 Months Before

Conduct a mock inspection — engage an external consultant to simulate the inspection process
Review recent batch records for completeness and accuracy
Verify that all CAPA records are closed or have documented timelines
Confirm that all personnel training records are current

1 Month Before

Prepare the inspection room and documentation index
Brief all staff who may be interviewed by inspectors
Confirm that key personnel (QP, QC manager, production manager) will be available during the inspection
Review the site master file for accuracy

During the Inspection

Provide accurate, complete answers to inspector questions — do not speculate or provide information you are not certain about
If you don’t know the answer to a question, say so and offer to find out
Document all inspector questions and observations in real time
Escalate any unexpected findings to senior management immediately

Key Regulatory References

Document	Official Source	Relevance
EudraLex Volume 4 — EU GMP Guidelines	European Commission	Full EU pharmaceutical GMP text
EN ISO 22716:2007 — GMP for cosmetics	ISO.org	Cosmetics GMP standard
EMA inspection procedure	EMA.europa.eu	GMP inspection framework
ICH Q10 — Pharmaceutical Quality System	ICH.org	Quality system lifecycle guidance
FDA 21 CFR Part 211	eCFR.gov	US cGMP for finished pharmaceuticals

Care Europe Perspective: In our pre-inspection assessments, the most frequently cited critical finding is not missing SOPs — it is SOPs that exist but are not followed in practice. Inspectors routinely compare documented procedures against batch records, logbooks, and direct observation. The gap between paper and practice is what fails inspections. Our audits focus equally on documentation completeness and operational adherence.

At Care Europe, we conduct GMP pre-inspection assessments for pharmaceutical and cosmetic manufacturers preparing for EU regulatory inspections. Contact us to discuss your inspection preparation timeline.

GMP Audit Preparation: What EU Inspectors Look For