HPRA inspections: what Ireland's regulator checks, how findings are graded and what is published

What the HPRA inspects

The Health Products Regulatory Authority (HPRA) inspects the companies that make, distribute and test medicines and devices in Ireland. For good manufacturing practice (GMP), that means sites making active substances, authorised medicines, medicines for clinical trials and veterinary medicines.

The HPRA also inspects sites outside the EU when it is their supervisory authority, which happens when the imported product is batch certified in Ireland. That certification is the job of a Qualified Person, covered in our guide on how to become a QP in Ireland.

Wholesalers, clinical trial sites, blood and tissue establishments and medical device companies are inspected too. The table shows the HPRA's own count for 2025.

Source: HPRA Annual Report 2025, published 11 September 2026.

For scale, our Ireland pharma map counts 331 operating manufacturing sites on the island of Ireland, so 108 human GMP inspections in a year is a large share of the Irish manufacturing base.

How often the HPRA inspects a site

The HPRA does not publish a fixed cycle for GMP inspections. It says most are part of its "national routine risk-based programme", with an inspection when a site applies for a manufacturer's authorisation and routine inspections after that.

Other inspections are "for cause" or "triggered", for example when a site plans new products or changes its production facilities. Notice is normally given, but the HPRA states that unannounced inspections can be performed where needed.

For wholesalers the HPRA is more specific. After a wholesale distribution authorisation is granted, a follow-up routine inspection usually takes place 18 to 24 months after the first one. After that, frequency depends on risk, judged on the site's activities and its past compliance history.

What happens during an HPRA GMP inspection

A routine HPRA GMP inspection follows a set pattern: notice, a request for documents, three to five days on site, then a written report. The steps below come from the HPRA's published procedure for routine national inspections.

1. Notice. The site is usually told 4 to 6 weeks ahead. The letter gives the legal basis, the scope, the inspectors' names and the number of days, with a list of documents to send first, such as the site master file and any significant changes since the last inspection.
2. Plan. The HPRA builds an inspection plan 1 to 2 weeks before the visit and may share it with the site if asked.
3. On site. Inspections are typically scheduled for 3 to 5 days, with an opening meeting, document review, a walk through the facilities, sessions with key personnel and a closing meeting. Some can be done remotely.
4. Report. A written report listing the deficiencies reaches the site within three weeks of the last day.
5. Response. The site has about three weeks to reply, with a root cause analysis and a corrective and preventive action (CAPA) plan for each finding, saying what will be done, by whom and when.
6. Close-out. Once the responses are accepted, the HPRA closes the inspection and issues a close-out letter by day 120.

Inspectors typically look at production areas, facilities and equipment (including computerised systems), starting materials, laboratories, quality system records, controls against contamination and mix-ups, and personnel and training. Sites that write good root cause analyses tend to find this stage easier; see our guides to CAPA and root cause analysis and deviation management.

HPRA inspection findings: critical, major and other

The HPRA grades every deficiency as critical, major or other. These are its own definitions, from its GMP inspection page.

• Critical: a deficiency that "has produced, or leads to a significant risk of producing either a product which is harmful to the human or veterinary patient or a product which could result in a harmful residue in a food producing animal".
• Major: a non-critical deficiency that has produced or may produce a product that does not comply with its marketing authorisation, or that shows a major deviation from EU GMP or from the manufacturing authorisation, a failure in batch release procedures, or a failure of the Qualified Person to fulfil their legal duties. Several "other" deficiencies can together count as a major one.
• Other: a deficiency that "cannot be classified as either critical or major, but which indicate a departure from good manufacturing practice", either because it is minor or because there is not enough information to grade it higher.

Where compliance is "significantly lower than the required standard", the findings go to the HPRA's Compliance Regulatory Group. That can lead to meetings with senior people at the company and a cautionary letter setting out what action is being considered.

HPRA inspection reports: what is published

The full inspection report goes to the site. What the public can see is the result recorded on EudraGMDP, the EU database run by the European Medicines Agency.

• GMP certificates. The HPRA issues a certificate on EudraGMDP within 90 days of the last day of an inspection, usually once the responses are accepted. It does not extend certificates; a current certificate on EudraGMDP shows it remains valid.
• Compliance management. A certificate issued during a compliance case carries a public note that it was "issued with administrative action(s)".
• Wholesalers. After a successful routine good distribution practice inspection, the HPRA issues a GDP certificate; new wholesale authorisations are issued to EudraGMDP electronically.
• Statements of non-compliance. Where a site does not meet the minimum GMP standard, a statement of non-compliance may be issued on EudraGMDP. The EMA made these public in December 2013; they set out the nature of the non-compliance and the action taken.

When we read EudraGMDP on 20 September 2026, 258 Irish sites held a GMP certificate, 426 certificates in all. The HPRA's yearly totals appear in its annual report, and upcoming regulatory dates are on our regulatory calendar.

HPRA inspections, the FDA and medical devices

For medicines, the US Food and Drug Administration (FDA) can rely on HPRA inspections under the EU-US mutual recognition agreement. The FDA confirmed Ireland's capability on 1 June 2018, according to the EMA.

The agreement does not end FDA visits to Irish plants. The FDA's questions and answers say both sides "reserve the right to inspect at any time and in any country", though such inspections are expected to be the exception. Our guide to FDA warning letters in Ireland shows what happens when an FDA inspection goes badly.

Medical device companies are inspected under a separate programme. The HPRA carries out proactive and for-cause inspections of device manufacturers, notified bodies, importers, distributors and authorised representatives, and did 32 in 2025, five of them jointly with other EU states. Device makers working to the transition dates can read our guide to EU MDR deadlines, and the wider rules are in our guide to GMP in Ireland.