GDP Developments - Update 2025 & 2026
Good Distribution Practice (GDP) is a core element in ensuring the quality, safety, and integrity of medicinal products throughout the entire supply chain. It ensures that products are stored, transported, and handled under controlled conditions from the manufacturer to the final recipient.
Over the past months, there have once again been numerous developments in the field of GDP. This article builds on the "GDP Update 2024/2025"1 published in Issue 43 of the GMP Journal and provides a concise overview of regulatory, supervisory, and practice-relevant developments between April 2025 and early 2026.
GDP Inspections and Non-Compliance Reports
First, it is worth examining the outcomes of regulatory inspections and the resulting regulatory expectations. If, during an inspection, a wholesaler's compliance with GDP cannot be confirmed, a corresponding non-compliance report is published in the EudraGMDP database.2 At the end of January 2026, a total of 53 reports from the years 2014 to 2025 were publicly accessible, noting that some older notifications had been withdrawn in the meantime.
During 2025, nine new reports were added. An analysis3 of these recent reports shows a particular focus on data integrity and IT security. Observations included unauthorized use of user accounts, inadequately defined access rights, deficiencies in password and role management, and insufficiently controlled remote access to quality-relevant systems. In several cases, quality-critical decisions had been made by unauthorized personnel. Additional deficiencies concerned the supply to unauthorized recipients, violations of statutory notification obligations, and shortcomings in cold chain management and temperature-controlled transport.
Publications by European Authorities
At the level of European regulatory authorities, several relevant publications were issued during the reporting period.
Swissmedic
In Switzerland, Swissmedic published various new and revised documents in 2025 within the "Inspectorates"4 section of its website that are directly relevant for GDP operations.
Recommendation
7/8 May 2026
Supply Chain of ATMPs - Live Online Training
Particularly noteworthy is Version 1.0 of the Technical Interpretation "Requirements for the return of medicinal products," effective as of 30 June 2025.5 For the first time, it defines clear time limits for product returns. Returns from a wholesaler's customer within ten days of delivery may generally be accepted. Returns between ten and a maximum of 30 days are permissible only if it can be demonstrated that the return is legitimate and does not constitute a resale, for example in the context of stock clearance. Returns after more than 30 days generally no longer meet GDP requirements and are considered unauthorized resale. Reintroduction into saleable stock is possible only in justified exceptional cases within the framework of formal deviation management.
Also relevant for GDP operations is the updated Technical Interpretation "Notifications according to Article 41, MPLO", published in Version 3.0 with effect from 21 May 2025.6 It clarifies which changes are considered substantial and therefore subject to mandatory notification. For GDP companies, this includes structural measures such as the construction or expansion of temperature-controlled storage areas, as well as the implementation or replacement of complex IT systems. These include ERP systems, automated warehousing and material flow systems, and software solutions incorporating elements of artificial intelligence or machine learning. Such changes must be notified to the authority in advance.
MHRA
A blog post published by the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate on 4 June 2025 addressed specific GDP challenges related to the supply of aircraft, ships, and oil platforms7 - locations that typically fall outside the standard scope of a wholesale distribution authorization. With reference to relevant UK and European legislation, the article emphasizes that even in such special cases, comprehensive customer qualification, full integration into the quality management system, and workable recall procedures are required.
In addition, on 16 May 2025, the MHRA published a further blog post concerning the validity of GMP and GDP certificates.8 The authority clarified that it does not intend to automatically extend GDP certificates that are approaching or have exceeded the five-year date since issuance. Although GDP certificates do not have a formal expiry date, companies remain responsible, as part of their due diligence obligations, for ensuring the continued GDP compliance of their sites.
HPRA
In Ireland, the Health Products Regulatory Authority (HPRA) published Version 8 of its Guide to Good Distribution Practice of Medicinal Products for Human Use.9 In addition to editorial updates, the 8 April 2025 version includes revised or expanded sections on supplier qualification, sourcing of unlicensed medicinal products, verification of safety features, assessment of customer authorization, and decommissioning of unique identifiers prior to supply.
GDP in the United States
GDP-related topics also remained in focus in the United States.
New USP Chapter <1079.5> and Stimuli Article
In the Pharmacopeial Forum, PF 51(5), a proposal for the new USP Chapter <1079.5> Transportation Lane Temperature Mapping and Qualification10, together with a related Stimuli article11, was published in 2025. The draft places increased emphasis on temperature mapping, systematic route risk assessment, and transportation lane management.
Stimuli Article on Controlled Room Temperature (CRT)
Another Stimuli article12, published in PF 51(3), addresses the harmonization of the USP definition of Controlled Room Temperature (CRT) with the requirements of other pharmacopoeias and the WHO, as current differences are regarded as a potential source of regulatory and practical inconsistencies.
Implementation of the DSCSA
In parallel, the phased implementation of the Drug Supply Chain Security Act (DSCSA) continued. The FDA and the Partnership for DSCSA Governance hosted several virtual town hall meetings during 2025 to discuss the current implementation status and remaining technical challenges. The background is the existence of time-limited exemptions13 for trading partners who have made significant progress in implementing electronic traceability systems but continue to face practical implementation challenges.
Practical Example: Outdoor Storage
A practical example illustrating the importance of appropriate storage conditions is provided by an FDA Warning Letter dated 25 June 2025.14 The outdoor storage of ethanol-containing bulk material was assessed as a clear violation of the declared storage conditions and the requirements of Good Manufacturing Practice (GMP). The case demonstrates that even for bulk material not yet filled or repackaged, compliance with specified storage conditions must be ensured and documented at all times. Failure to do so may-result not only in quality deterioration but also in regulatory actions, product recalls, and significant reputational damage.
Recommendation
17/18 June 2026
Stability Studies to Support Shipping/Distribution of Pharmaceuticals and Biopharmaceuticals - Live Online Training
Falsified Medicinal Products
The issue of falsified medicinal products also remained highly relevant in 2025. In an information notice dated 27 March 202515, Swissmedic reported on a targeted inspection campaign focusing on international trade with suppliers from non-EU countries. Of 73 identified Swiss companies holding the authorization module "Import for export," 16 were inspected.16 While no deficiencies were identified in seven companies, five submitted insufficient documentation, and four were found to have minor deficiencies. In particular, authorities criticized the lack of complete traceability of medicinal products back to the marketing authorization holder. In some cases, an impermissible combination of pharmacy and wholesale activities was also identified.
Surveys
In addition to regulatory activities, several surveys provided valuable insights into practical GDP implementation.
Biopharmaceutical Drug Substance
A BioPhorum survey17 published on 5 September 2025 on the storage of biopharmaceutical active substances at -40 °C shows that this practice is widespread and considered regulatorily manageable, provided robust stability data, appropriate packaging-systems, and controlled transportation processes are in place.
Transport Validation
In June 2025, the Parenteral Drug Association published the results of a benchmarking survey18 on transport validation, highlighting strategies for the qualification of temperature-controlled transport systems.
Supply Chain 2035
A study conducted by Kühne Logistics University (KLU) in collaboration with SAP Supply Chain Consulting aimed to assess how supply chain management is expected to evolve in the coming years.19 The results, published in a series of articles in the Deutsche Verkehrs-Zeitung (DVZ)20, indicate that companies are increasingly applying digitalization and artificial intelligence in a pragmatic manner - specifically where clear added value can be achieved in planning, resilience, and delivery performance.
For GDP practice, the findings underline in particular the growing importance of robust IT systems, clearly defined data responsibilities, and the increasing use of AI-supported planning and monitoring processes.
GDPA
In 2025, the European GDP Association (GDPA) conducted a comprehensive survey on the practical implementation of GDP requirements. Approximately 200 professionals from around 40 countries participated. The results21 reveal, among other findings, significant differences in the interpretation of wholesale distribution authorizations, the role of the Responsible Person, and the use of electronic quality systems. The majority of respondents indicated that they conduct regular self-inspections and mock recalls and apply temperature monitoring to all shipments. A detailed evaluation report22 is available free of charge in the members' areaof the GDPA website. Membership is free of charge and can be obtained via a simple online application form.23
EMA Three-Year Work Plan
Finally, attention should be drawn to the three-year work plan (2025-2027)24 of the GMDP Inspectors Working Group published by the European Medicines Agency (EMA), as well as the 2024 annual report.25 Both documents provide insight into the future regulatory direction of GMP and GDP supervision within the European Union and highlight topics expected to gain importance in the coming years. Key priorities include a more risk-based inspection approach, increased focus on IT systems and data integrity, and measures to strengthen supply chain resilience. In addition, the publications indicate that procedural harmonization, management of new regulatory requirements, and prevention of falsified medicinal products will continue to gain significance.
About the Author
Dr Markus Funk is Operations Director at CONCEPT HEIDELBERG and organises and conducts courses and conferences on behalf of the ECA Academy in analytical and GDP topics.
Notes:
1 GMP Journal, GDP Update 2024/2025, https://www.gmp-journal.com/current-articles/details/gdp-update-for-2024-2025.html
2 EudraGMDP, GDP Non-Compliance Reports, https://eudragmdp.ema.europa.eu/inspections/view/gdp/searchGDPNcr.xhtml?search=nonCompliance
3 ECA, The GDP Non-Compliance Reports of 2025 - An Overview, https://www.gmp-compliance.org/gmp-news/the-gdp-non-compliance-reports-of-2025-an-overview
4 Swissmedic, Inspectorates, https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/bewilligungen_zertifikate/authorisations/inspectorates.html
5 Swissmedic, Requirements for the return of medicinal products, I-SMI.TI.28e, Version 1.0,
https://www.swissmedic.ch/dam/swissmedic/de/dokumente/bewilligungen/inspektorat/i-smi.ti.28e-requirements-return-of-medicinal-products.pdf.download.pdf/I-SMI.TI.28e_Return_of_medicinal_products_V01.pdf
6 Swissmedic, Notifications according to Article 41, MPLO, I-SMI.TI.22e, Version 3.0,
https://www.swissmedic.ch/dam/swissmedic/de/dokumente/bewilligungen/inspektorat/i-smi_tj_22e_notifications_art_41_mplo.pdf.download.pdf/I-SMI.TI.22e_Notifications_Art_41_MPLO.pdf
7 MHRA, A Voyage in Good Distribution Practice (GDP): The Aviation and Marine Sectors,
https://mhrainspectorate.blog.gov.uk/2025/06/04/a-voyage-in-good-distribution-practice-gdp-the-aviation-and-marine-sectors/
8 MHRA, GMP & GDP Certificates, https://mhrainspectorate.blog.gov.uk/2025/05/16/gmp-gdp-certificates/
9 HPRA, Guide to Good Distribution Practice of Medicinal Products for Human Use, IA-G0046-8,
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/ia-g0046-guide-to-good-distribution-practice-of-medicinal-products-for-human-use-v8.pdf?sfvrsn=f185f63b_17
10 Pharmacopeial Forum, <1079.5> Transportation Lane Temperature Mapping and Qualification,
https://online.uspnf.com/uspnf/document/2_GUID-2BFE0692-FBF6-4D95-B0BC-506F73F633F6_10101_en-US
11 Pharmacopeial Forum, Transportation Lane Temperature Mapping and Qualification—Risk Identification and Evaluation,
https://online.uspnf.com/uspnf/document/2_GUID-54EA1962-B912-42FA-B3CB-3B14D46A8D70_10101_en-US
12 Pharmacopeial Forum, Aligning Room Temperature Standards for Pharmaceuticals—A Sustainable Approach,
https://online.uspnf.com/uspnf/document/2_GUID-485CBA1F-4020-45D7-A258-6715085D1159_10101_en-US
13 FDA, Waivers and Exemptions Beyond the Stabilization Period, https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/waivers-and-exemptions-beyond-stabilization-period
14 FDA, Warning Letter Nature’s Fusions LLC, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/natures-fusions-llc-707024-06252025
15 Swissmedic, Falsified medicinal products entering the supply chain: Swissmedic intensifies controls on international trade with suppliers from non-EU countries,
https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/medicinal-products-from-the-internet/warnings-related-to-medicinal-products-from-the-internet/
gefaelschte-am-in-lieferkette.html
16 Swissmedic, Swissmedic intensifies controls on international trade with suppliers from non-EU countries,
https://www.swissmedic.ch/dam/swissmedic/en/dokumente/marktueberwachung/illegal/gefaelschte-am-arzneimittel-in-lieferkette.pdf.download.pdf/EN_Schwerpunktaktion_KIA-V1.pdf
17 BioPhorum, Biopharmaceutical drug substance storage, https://www.biophorum.com/download/biopharmaceutical-drug-substance-storage-biophorum/
18 PDA, PDA Survey: 2025 Transportation Validation Benchmarking Survey, https://www.pda.org/bookstore/product-detail/8363-pda-survey-2025-transportation-validation
19 Kühne Logistics University – How Supply Chain Management will work in the future, https://www.klu.org/article/how-supply-chain-management-will-work-in-the-future/
20 Deutsche Verkehrs-Zeitung (DVZ), Serie: Supply Chain 2035, https://www.dvz.de/scm2035.html
21 ECA, GDP Implementation Survey: Brief Summary, https://www.gmp-compliance.org/gmp-news/gdp-implementation-survey-brief-summary
22 European GDP Association, https://gdp.gmp-compliance.org/
23 European GDP Association, Register for Membership, https://gdp.gmp-compliance.org/membership/registration.html
24 EMA, Three year work plan for the Good Manufacturing Practice / Good Distribution Practice Inspectors Working Group 2025-2027,
https://www.ema.europa.eu/en/documents/work-programme/three-year-work-plan-good-manufacturing-practice-good-distribution-practice-inspectors-working-group-2025-2027_en.pdf
25 EMA, Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2024,
https://www.ema.europa.eu/en/documents/annual-report/annual-report-good-manufacturing-distribution-practice-inspectors-working-group-2024_en.pdf
