22 June 2023
The wholesale distribution of medicinal products requires a Wholesale Distribution Authorisation (WDA). Within the European Union, these authorisations are issued by the national competent authority of the member state in which the wholesale distributor operates.
The member states shall enter the GMP and GDP certificates which they issue in the EudraGMDP. This database is maintained and operated by the European Medicines Agency (EMA). If the outcome of an inspection is that a wholesale distributor does not comply with Good Distribution Practice, a statement of non-compliance may be entered into EudraGMDP.
The number of GDP Non-Compliance Reports entered into the EudraGMDP database in 2022 is – like the total number of reports – quite low. At the beginning of this year (as of 11 January 2023), a total of 33 reports from 2014 to 2022 were available via the free and publicly accessible read-only access. However, this does not reflect the total number of all GDP Non-Compliance Reports, as some documents have been withdrawn in the meantime and are therefore no longer displayed. For example, only 9 of the 11 reports posted in 2022 were available for download at the beginning of January 2023.
In 2022, 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||Remarks|
The following table provides an overview of the deficiencies that led to the issuing of the 11 GDP Non-Compliance Reports of 2022. The deficiencies mainly relate to the requirements from Chapters 1 to 5 of the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01).
In each case, an attempt was made to assign the deficiency in question to a subchapter. The total number of deficiencies is greater than the number of reports because most documents list several independent items. Typically, therefore, it was not a single deficiency but rather numerous deviations that led the respective authority to issue the GDP Non-Compliance Report.
CHAPTER 1 —
|1.2. Quality system||4|
|1.3. Management of outsourced activities||---|
|1.4. Management review and monitoring||---|
|1.5. Quality risk management||---|
|CHAPTER 2 — |
|2.2. Responsible person||7|
|2.3. Other personnel||---|
CHAPTER 3 —
|3.2.1. Temperature and environment control||2|
|3.3.1. Computerised systems||---|
|3.3.2. Qualification and validation||1|
|CHAPTER 4 — |
|CHAPTER 5 — |
|5.2. Qualification of suppliers||3|
|5.3. Qualification of customers||2|
|5.4. Receipt of medicinal products||---|
|5.6. Destruction of obsolete goods||---|
|5.9. Export to third countries||---|
(not to be assigned to specific chapters)
Since the individual deficiencies are typically described only very briefly in the reports, certain uncertainties cannot be excluded in the categorization made. It should also be noted that the reports often list only the critical and major deficiencies, although there may have been other deficiencies as well. In principle, however, the following can be summarized:
Many of the deficiencies documented in the GDP Non-Compliance Reports relate to the responsible person. Either the availability of a responsible person was not ensured, or the person did not perform his or her duties to the required extent.
Another focus is on the premises (Chapter 3). In this regard, for example, it was repeatedly criticized that activities were carried out in premises not covered by the authorization. Inadequate access controls and the lack of temperature monitoring were also mentioned several times.
The principles set out in Chapter 5 (Operation) were likewise not fulfilled by the companies concerned in several cases, for example because the authorities had doubts whether proper operation was possible at all. The lack of qualification of suppliers and customers was also mentioned several times.
Finally, several reports criticized the quality System (Chapter 1) and the lack of documentation (Chapter 4).