Good Distribution Practice (GDP) inspections
A Good Distribution Practice (GDP) inspection is an inspection of a wholesale distribution site for medicines or active substances to ensure compliance with the principles of GDP. We inspect wholesaler's of medicines or active substance distributor site for compliance with GDP. If a company is not in compliance with GDP, a deficiency will be cited.
Different types of GDP inspection
- An initial GDP inspection as part of a new application for a Wholesale Distribution Authorisation (WDA) or Active Substance Registration (ASR).
- Routine GDP inspections occur on an ongoing basis to ensure continuous compliance with EU GDP guidelines after a WDA or ASR is granted.
- Non-routine inspections in relation to an application by the company to make changes to activities (a variation application).
- Non-routine inspections can occur in response to an issue that is considered a risk for compliance with EU GDP guidelines and/or to public health (a for-cause inspection).
Frequency of GDP inspection
After a WDA or ASR is granted, a follow-up routine inspection of the site usually takes place 18-24 months after the initial inspection.
The frequency of the routine inspections thereafter will be determined based on risk. Risk factors may be intrinsic to the activities at the site and/or past compliance history.
Process for GDP inspection
The process of a GDP Inspection is similar, but not the same for every company. Some differences based on the type of GDP inspection have been flagged where applicable.
After the inspection
Following a successful inspection for a new application, the HPRA Inspection team will issue an electronic WDA or ASR to EudraGMDP. A GDP cert will be issued for routine inspections following a successful outcome of the GDP inspection.
Will a hard copy of the authorisation be issued?
The HPRA do not routinely issue hard copies of Manufacturing Authorisations (MIAs), Wholesale Distribution Authorisation (WDAs) and Active Substances Registrations (ASRs). These can be found on the EudraGMDP website. The authenticity or integrity of electronic authorisations may be verified on the EudraGMDP database.
Further Information
We have provided links to some essential guidance and special topics relating to wholesaling in Ireland below.
You can send any queries to the Licensing Section of the HPRA. Please see the Contact Us page.
Essential guidance for wholesaling in Ireland
- The European Commission's Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01).
- The European Commission’s Guidelines on Good Distribution Practice of Active Substances for Medicinal Products (2015/C 95/01).
- EU Regulations on Good Distribution Practice for Active Substances used as starting materials in Veterinary Medicinal Products (Regulation (EU) 2021/1280).