News

FDA Warning Letter: Inadequate Warehouse Controls and Lot Traceability

A recent Warning Letter issued by the U.S. Food and Drug Administration (FDA) highlights how inadequate quality unit oversight, warehouse segregation and lot-level traceability can undermine the control of OTC drug products.

More
European GDP Association Developments May through August 2026

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

More
Reminder: Submit your Presentation Proposal for the GDP Forum 2027 by 30 September

Last month, we published our call for presentations for the GDP programme of the GMP & GDP Forum 2027 in Berlin. Experts from industry, regulatory authorities and consultancy, as well as other professionals involved in GDP, can still submit a proposal on practical projects, lessons learnt and current topics such as artificial intelligence, modern quality systems and digitalisation. The deadline for submissions is 30 September 2026.

More
GDP in the US: FDA Launches DSCSA Assessment for Small Dispensers and Issues Exemptions

The U.S. Food and Drug Administration (FDA) is encouraging small dispensers, defined as pharmacies with 25 or fewer full time employees, to complete a survey by 22 September 2026. In addition, the FDA is issuing exemptions from certain requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act for small dispensers and, where applicable, their trading partners until 27 November 2027.

More
Q&A Version 22 on Safety Features for Medicinal Products

Version 22 of the Q&A on Safety features contains important clarifications regarding regulatory authorities’ access to Audit Trail data.

More
GDP for APIs: APIC Publishes Updated "How to Do" Document

An updated version of the document “GDP for APIs: How to do” has been published on the APIC website. In addition to other revisions, the guide now also includes practical guidance on the good distribution practice of active substances used as starting materials in veterinary medicinal products.

More
Where to Find Information on UK Wholesale Authorisations

During several GDP events in the first half of 2026, participants asked where to find information on currently valid and no longer valid wholesale distribution authorisations in the United Kingdom. The UK Medicines and Healthcare products Regulatory Agency (MHRA) provides this information and last updated its register of licensed wholesale distribution sites in July 2026.

More
Call for Presentations: GDP Forum 2027 in Berlin

Since 2021, the GMP & GDP Forum has taken place every two years, bringing together the European GMP Conference and the European GDP Forum. The next event will take place from 22 to 24 June 2027 in Berlin, Germany. We are inviting interested experts to submit proposals for presentations as part of the GDP programme.

More
Questions and Answers from the ECA Webinar "GDP Update 2026" - Part 5

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 5 (final part) here, covering the topics of MKT, EMA, and miscellaneous topics.

More
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.

More
x
Search