The GDP Non-Compliance Reports of 2023 - An Overview

Recommendation

12 September 2024
Basel, Switzerland

GDP in Switzerland (GDP 3)
Specifics in the Distribution of Medicinal Products (Course in english language!)

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.

As in previous years, we have prepared an overview of the GDP Non-Compliance Reports published in 2023 and the respective reasons for issuing these reports.

Number of Reports

As of 10 January 2024, a total of 41 reports from 2014 to 2023 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 However, this does not reflect the total number of all GDP Non-Compliance Reports, as some documents have been withdrawn over the years and are therefore no longer displayed.

10 out of the 11 reports posted in 2023 were available for download at the beginning of January 2024.

Overview of the Reports entered in 2023

In 2023, 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
sukls223529/2022	2023-01-27	Czechia
sukls22447/2023	2023-02-01	Czechia
sukls32154/2023	2023-02-09	Czechia
sukls39183/2023	2023-02-15	Czechia
sukls68453/2023	2023-04-26	Czechia
IIBPD/FRG/20230811	2023-08-31	Spain	Report withdrawn
01	2023-10-06	Germany
INS-482779-14059355	2023-10-09	Austria
INS-484035-102397839	2023-10-09	Austria
sukls67268/2023	2023-11-13	Czechia
481791-101212189	2023-12-07	Austria	API distributor

Type of Deficiencies

The following table provides an overview of the deficiencies that led to the issuing of the 11 GDP Non-Compliance Reports of 2023. The deficiencies mainly relate to the requirements from Chapters 1 to 6 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	Subchapter	Quantity
CHAPTER 1 — QUALITY MANAGEMENT	1.1. Principle	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 — PERSONNEL	2.1. Principle	---
	2.2. Responsible person	6
	2.3. Other personnel	1
	2.4. Training	---
	2.5. Hygiene	---
CHAPTER 3 — PREMISES AND EQUIPMENT	3.1. Principle	5
	3.2. Premises	7
	3.2.1. Temperature and environment control	1
	3.3. Equipment	---
	3.3.1. Computerised systems	---
	3.3.2. Qualification and validation	---
CHAPTER 4 — DOCUMENTATION	4.1. Principle	1
	4.2. General	2
CHAPTER 5 — OPERATIONS	5.1. Principle	9
	5.2. Qualification of suppliers	2
	5.3. Qualification of customers	---
	5.4. Receipt of medicinal products	1
	5.5. Storage	8
	5.6. Destruction of obsolete goods	---
	5.7. Picking	---
	5.8. Supply	2
	5.9. Export to third countries	1
CHAPTER 6 — COMPLAINTS, RETURNS, SUSPECTED FALSIFIED MEDICINAL PRODUCTS AND MEDICINAL PRODUCT RECALLS	6.1. Principle	1
	6.2. Complaints	---
	6.3. Returned medicinal products	---
	6.4. Falsified medicinal products	---
	6.5. Medicinal product recalls	---
OTHERS (not to be assigned to specific chapters)		2

Short Evaluation

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:

Like in 2022, 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) and storage (Chapter 5). In this regard, it was repeatedly criticized that activities were carried out in premises not covered by the authorisation. In particular, the competent authority of Czechia has issued a couple of reports mentioning this type of deficiency.
It was also mentioned that warehousing operations (Chapter 5) do not guarantee proper stock security.
Several reports criticized the quality System (Chapter 1), which was not applied and maintained or does not guarantee that the supplied products remain within the legal supply chain.
Finally, the documentation (Chapter 4) was mentioned, in particular that purchase and sales were not documented adequately.