GDP Implementation Survey: Brief Summary

As previously reported, the European GDP Association (GDPA) conducted a survey on the practical implementation of GDP requirements in the pharmaceutical supply chain. Participation in the survey was possible until 31 July 2025.

The survey sheds light on the current state of GDP implementation, regional differences, practical challenges, as well as expectations of authorities and industry-specific development trends. Exactly 200 individuals from around 45 countries took part in the survey – including representatives from pharmaceutical manufacturers, wholesalers, logistics service providers, marketing authorisation holders (MAHs), regulatory authorities, and consulting firms. Approximately half of the respondents were members of the GDPA. Not all participants answered every question, as it was possible to skip individual items.

A detailed report with all findings and an in-depth evaluation of the results is currently being prepared and is expected to be made available for free download in the members’ area of the GDPA website in September. Below you will find a brief summary of selected results.

Participant Profile

Just under 30% of respondents were employed by a marketing authorisation holder (MAH), around 13% by a full-line wholesaler, and 11% by a short-line wholesaler. Other roles included manufacturers (15%), logistics service providers (12%), consultants (approx. 10%), and competent authorities (3%).

About one quarter of respondents work for companies with 11–50 employees. Roughly one fifth each work in companies with more than 1,000 employees or with 101–500 employees. Small companies with fewer than ten employees accounted for about 18%.

Geographically, nearly three-quarters of responses came from EU Member States. In addition, participants from Switzerland, the United Kingdom, and a smaller number from Africa, Asia, the Americas, and the Middle East were represented.

Marketing Authorisation and Distribution Structures

A central topic was the necessity and structure of the Wholesale Distribution Authorisation (WDA). Around 42% of respondents indicated that MAHs in their country are required to hold a WDA, while 46% said this is not the case. The remaining participants were unsure.

83% stated that a WDA is also required when medicines are bought or sold without physical handling.

When asked whether medicinal product categories are listed on the WDA, 55% replied that only basic categories such as cold chain products or narcotics are specified. About two-thirds stated that contract warehouses must be listed in their WDA.

The Role of the Responsible Person (RP)

With regard to the qualifications of the Responsible Person, participants were asked whether the RP must legally be a pharmacist. About 31% said this is a formal legal requirement in their country. Around 37% stated that it is not mandatory but is recommended or expected by authorities. Nearly 30% reported that there is neither a legal requirement nor an expectation from the authorities.

Slightly more than half of the respondents said that appointing a deputy RP is not mandatory.

Additional Topics

According to approximately 40% of respondents, self-inspections are conducted either annually or based on risk. Regarding the scope of these inspections, 41% indicated that all aspects of the quality management system (QMS) are covered in each self-inspection – meaning not only selected topics are reviewed.

77% of participants reported using electronic systems in their companies, e.g., for QMS or CAPA management.

Nearly three-quarters of respondents confirmed that temperature monitoring is carried out for all shipments. 69% stated that risk assessments are performed for each transport route.

The majority of participants have defined recall processes in place that are tested regularly. Over 90% reported conducting mock recalls on a regular basis and being required to do so. Likewise, 90% stated that these exercises are conducted once per year.