An EU good manufacturing practice (GMP) inspection is not an event to prepare for in the final weeks before an inspector arrives — it is a state a site must be able to demonstrate at any moment. For companies manufacturing or importing medicinal products for the Greek and wider EU market, a smooth inspection protects the manufacturing authorisation, the supply chain and, ultimately, patient safety. Genuine readiness is built continuously, long before the notification letter lands.
The framework inspectors work from
EU GMP requirements are set out in EudraLex Volume 4, the compilation of guidelines that national competent authorities apply across the EU and EEA. In Greece, the National Organisation for Medicines (EOF) is the competent authority responsible for GMP inspections, operating within the harmonised European and PIC/S framework. Following an inspection, the authority records the outcome in the publicly accessible EudraGMDP database — issuing a GMP certificate for a positive result or a non-compliance report where serious deficiencies are found. An EU GMP certificate is generally regarded as valid for three years, though the issuing authority may apply a shorter validity based on risk.
Recent expectations that raise the bar
The framework continues to evolve, and inspectors expect sites to keep pace. Two areas deserve particular attention:
- The revised Annex 1 on the manufacture of sterile medicinal products was published in August 2022 and became effective on 25 August 2023 (with the provision on lyophiliser sterilisation applying from 25 August 2024). It places a formal contamination control strategy (CCS) at the centre of sterile manufacturing.
- Data integrity remains a recurring focus. Inspectors assess records against the ALCOA+ principles — attributable, legible, contemporaneous, original and accurate — and scrutinise computerised systems in line with Annex 11.
Common findings that derail inspections
Many observations recur across sites and are avoidable with disciplined systems:
- Deviations and CAPAs left open, poorly investigated, or without a robust root-cause analysis.
- Incomplete or contradictory documentation, and batch records that do not reflect what actually happened on the floor.
- Weak data integrity controls, such as shared logins, disabled audit trails or unreviewed electronic data.
- An underdeveloped or purely theoretical contamination control strategy in sterile and aseptic areas.
- Supplier and outsourced-activity oversight that cannot be evidenced through qualification and quality agreements.
Building a state of continuous readiness
Sustainable readiness comes from a functioning pharmaceutical quality system rather than a pre-inspection scramble. Practical priorities include a self-inspection and internal audit programme that genuinely challenges the site, timely closure of deviations and CAPAs, current and controlled documentation, and staff who can confidently explain their own processes. Mock inspections and management reviews help surface gaps while there is still time to correct them, and a clear plan for hosting the inspection — a prepared back room, subject-matter experts on call and controlled document retrieval — keeps the day itself calm and credible.
How PQRA helps
PQRA supports pharmaceutical companies and healthcare innovators across the full quality assurance lifecycle: GMP and GDP gap assessments, mock inspections and audit readiness, remediation of findings, and the design of practical, inspection-ready quality systems. We help sites in Greece and across the EU translate regulatory expectations into day-to-day practice, so that an inspection confirms what is already working rather than exposing what is not.
To discuss preparing your site for an EU GMP inspection, get in touch with the PQRA team.
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