News

GDP in Hong Kong: Authority Provides Additional Information

As previously reported, the competent authority in Hong Kong, the Pharmacy and Poisons Board, launched a public consultation on the introduction of Good Distribution Practice (GDP). The consultation has now been completed. The authority has now published additional information in a presentation, which is available for download as a PDF file.

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GDP Non-Compliance Report: Spanish Authority Found 29 Deficiencies During an Inspection of a Wholesale Distributor

The Spanish competent authority has published a new GDP Statement of Non-Compliance on EudraGMDP. An inspection identified 29 deficiencies across the company’s GDP system, including 8 critical and 10 major findings.

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GDP Inspection Responses: MHRA’s Expectations for AI Use in GxP Replies

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a new post entitled “Use of AI for GXP inspection responses: setting standards without stifling innovation” on the Inspectorate blog. The article focuses on submissions to the MHRA Compliance Teams following GxP inspections and is therefore also relevant for GDP-regulated activities.

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FDA Warning Letter to Amazon: Unapproved New Drugs Sold via Online Marketplace

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to Amazon.com, Inc. following an FDA review of labeling and marketing claims for drug products purchased via the website and distributed to U.S. consumers through the “Fulfillment by Amazon” service.

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USP Proposes to Revise the Definition of Controlled Room Temperature in Chapter <659>

The United States Pharmacopeia (USP) has published a proposal to revise General Chapter <659> Packaging and Storage Requirements, focusing on the compendial definition of Controlled Room Temperature (CRT). The aim is to better align USP terminology with the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia (JP) and WHO usage, where “room temperature” is defined as 15–25 °C.

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GDPA Participated as an Observer in the EMA GMDP-IWG Interested Parties Meeting

On 11 June 2026, the “Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group Interested Parties Meeting” took place online. Alfred Hunt attended on behalf of GDPA as an observer, supporting the association in staying closely connected to regulatory discussions and tracking upcoming GDP developments early.

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GDP Non-Compliance Report: Missed CAPA Timelines lead to Refusal of GDP Certificate

Latvia’s competent authority published a GDP Statement of Non-Compliance in EudraGMDP dated 19 May 2026. The case shows that missed CAPA deadlines and insufficient evidence of compliance can result in refusal of a GDP certificate, even if no immediate product risk is identified.

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Questions and Answers from the ECA Webinar "GDP Update 2026" - Part 4

Around 120 participants attended the ECA Webinar “GDP Update 2026” in March. Many interesting aspects were discussed during the Q&A session. After the event, the speaker, Dr Christian Grote-Westrick, provided written responses to the submitted questions. We have compiled a selection of these questions and answers for you – read Part 4 here, covering the topics of veterinary medicinal products and computer system validation (CSV) / artificial intelligence (AI).

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European GDP Association Developments January through April 2026

Find out what the European GDP Association was working on and accomplished in the first four months of 2026 - in the latest report.

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Questions and Answers from the ECA Webinar "GDP Update 2026" - Part 3

Around 120 participants attended the ECA Webinar “GDP Update 2026” in March. Many interesting aspects were discussed during the Q&A session. After the event, the speaker, Dr Christian Grote-Westrick, provided written responses to the submitted questions. We have compiled a selection of these questions and answers for you – read Part 3 here, covering the topics of transport validation and Annex 15.

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