The GDP Non-Compliance Reports of 2021 - An Overview
Recommendation
3/4 December 2024
How to conduct and pass GDP Audits and Inspections
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Wholesale trade in medicinal products requires a wholesale authorisation. A certificate of Good Distribution Practice (GDP) is issued to a wholesale distributor by the national competent authority.
If the outcome of an inspection is that the wholesale Distributor does not comply with Good Distribution Practice, a statement of non-compliance may be entered into EudraGMDP. The EudraGMDP database is maintained and operated by the EMA.
Number of Reports
The number of GDP non-compliance reports entered into the EudraGMDP database in 2021 is – like the total number of reports – quite low. The following table gives an overview of the number of reports in recent years:
| Year | Number of GDP non-compliance reports |
| 2021 | 6 |
| 2020 | 6 |
| 2019 | 6 |
| 2018 | 4 |
| 2017 | 1 |
| 2016 | 1 |
| 2015 | 0 |
| 2014 | 1 |
| Total | 25 |
Evaluation of the Reports entered in 2021
In 2021, the following reports were entered into the database (by clicking on the report number, you will get to a summary of the respective report):
| Report Number | Issue Date | Country |
| 24.05.01.17-03-0126 | 2021-12-03 | Germany |
| G3-6300.GH_Rowi-Med_20210816 | 2021-10-01 | Germany |
| sukls162731/2021 | 2021-08-06 | Czechia |
| NCD/011/RO | 2021-04-15 | Romania |
| 1 | 2021-03-05 | Germany |
| NCD/010/RO | 2021-01-22 | Romania |
The following table gives an overview of the deficiencies that led to issuing of the GDP non-compliance reports entered in 2021. The total number of deficiencies is greater than the number of reports, as in some cases several topics were listed:
| Area | Details | Quantity |
| Responsible Person (RP) | Doubtful reliability / No responsible person who possesses the required expert knowledge / RP does not properly perform his or her duties | 4 |
| Premises / storage | No suitable and adequate premises or storage areas, installations and facilities / Storage of expired medicinal products in between those ready for trading / Storage of expired medicinal products in regular stock | 4 |
| Procurement | Procuring from entities which are not authorized for wholesaling activities / Trading of medicinal products with unclear trade chain | 2 |
| Quality system | No GDP conform quality system | 1 |
| Change Management | No change control system | 1 |
| Deviations | Deviations were not documented | 1 |
| Self-Inspections | No self-inspections were performed | 1 |
| Training | Information on staff training could not be provided | 1 |
| Counterfeit medicines | Trading of falsified medicinal products | 1 |
| CEO | Doubtful reliability | 1 |
| Others | Missing connection to the securepharm-system / Company changed its address without information to or inspection of the competent authority | 2 |
Related GMP News
19.11.2024Swissmedic updates Guideline for Conducting Inspections
19.11.2024BioPhorum Article on Resilience of the Supply Chain
19.11.2024Romanian Authority Issues two new GDP Non-Compliance Reports
10.10.2024SwissGMDP Database now available
10.10.2024New MHRA Guidance for Wholesalers and Manufacturers