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.
Notification
Normally, the company will be notified via email six weeks in advance of the proposed inspection date. The notification will include:
- List of the inspectors
- Duration of the inspection
- List of documents to be prepared in advance of the inspection.
For non-routine inspections, the company may not be notified in advance.
Inspection conduct
Inspections usually begin with an opening meeting and end with a closing meeting. The HPRA Inspection Team will review records available and they may interview staff assigned to GDP operations as part of the inspection.
The Team will focus on compliance of the wholesaling operation with the EU Guide to Good Distribution Practice (GDP) and associated legislative requirements. During a non-routine inspection, specific areas may be prioritised based on an application or issue considered to be a significant risk.
Issuance of an inspection report
An inspection report is issued following any type of inspection. The deficiencies of the inspection will be classified into three categories: 'Critical', 'Major', and 'Other'.
'Critical' deficiency
A Critical deficiency is considered a deviation from EU GDP Guidelines resulting in a medicine or active substance which could be considered a significant risk to the patient and public health. Certain activities of concern include:
- Any activity increasing the risk of falsified medicines reaching the patients.
- Also, a combination of associated 'Major' deficiencies may meet the 'Critical' classification when present together.
'Major' deficiency
A Major deficiency is considered a deviation from EU GDP Guidelines resulting or likely to result in a medicine or active substance which does not comply with the issued authorisations or registrations. Certain activities of concern include:
- Any activity which does not comply with the required conditions, particularly storage and transport conditions.
- Any activity which does not comply with the wholesale distribution authorisation (WDA) or active substance registration (ASR).
- A combination of associated 'Other' deficiencies may meet the 'Major' classification when they are present together.
'Other' deficiency
An Other deficiency is a deviation from EU GDP Guidelines which cannot be classified as either a 'Critical' or 'Major deficiency'.
Company response to report and close-out
The company must prepare a response to each individual deficiency and point for clarification that is outlined in the inspection report. The company response must include any proposed/completed corrective action(s) and date(s) for completion of the corrective action(s).
Further correspondence may occur until the HPRA Inspection Team concludes that the company responses are satisfactory.
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).