In April 2026, the IPEC announced the updated Version 3 of the ‘Qualification of Excipients for Use in Pharmaceuticals: Guide & Checklist’ on its website. This guide was first published in 2008 and is currently only available in the IPEC members’ area.
The European Medicines Agency (EMA) has published on its website the 3-year work plan (2026–2028) of the GMDP Inspectors Working Group (GMDP IWG) as well as the 2025 annual report. In addition to numerous GMP-related topics, both documents also highlight important aspects that are relevant to the GDP area.
In April 2026, the updated texts of Ph. Eur. 13.1 were published and listed on the EDQM website under the Ph. Eur. section. These include, for example, the revised general chapter '2.1.7. Balances for analytical purposes'.
Following the revision of the ICH Q9 guideline 'Quality Risk Management 2023', the accompanying training material was also published. This has now been updated with regard to the two annexes. Annex I describes quality risk methods and tools, and Annex II describes possible applications of quality risk management (QRM).
During the inspection of a US site belonging to a French pharmaceutical manufacturer, the FDA identified serious deficiencies, including in a process system for the manufacture of OTC drugs. The deficiencies relate to both the equipment design and its qualification. Read more here.
A warning letter from the FDA highlights the importance of microbiological and analytical testing of medicinal products. For example, it criticises inadequate testing of culture media with GPT and a lack of BCC testing.
The U.S. Food and Drug Administration (FDA) has published a new Warning Letter that refers back to an inspection at a Chinese drug manufacturing facility. At the center of the letter is an analytical compliance failure frequently cited in Warning Letters: release decisions without appropriate laboratory evidence.
A recent FDA Warning Letter joins a long list of similar observations and confirms that CAPAs and Root Cause Analysis remain among the most common and critical weaknesses in GMP systems.
A new question has been added to the FAQs section of the EDQM website under the subheading 'Application dossier'. You can find this in the section 'CERTIFICATION OF SUBSTANCES FOR PHARMACEUTICAL USE' under the main heading 'General information on the CEP procedure'. The new question reads: "How to present the specification for a substance in a CEP application?".
