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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?".

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FIFO, FEFO and LIFO are the three main strategies for warehouse management. But what do the three abbreviations actually stand for and what exactly do they mean?

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The FDA has published a draft guidance on how pharmaceutical manufacturers should respond to FDA Form 483 observations after a CGMP inspection. The document emphasises clear, concise, and risk-based responses that address root causes and demonstrate effective corrective actions.

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In mid-February 2026, a summary of the comments received during the public consultation on the "ICH M4Q(R2) Guideline on the Common Technical Document for the registration of pharmaceuticals for human use: Quality" was published on the EMA website.

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In a recent Warning Letter, the U.S. Food and Drug Administration (FDA) identified significant weaknesses in laboratory controls, missing analytical validation, and an inadequate stability program.

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Although the document "The worksharing procedure for the assessment of Active Substance Master File (ASMF)" by the two coordination groups CMDh and CMDv had only just been updated in May 2024, another amendment was made at the end of 2025. The current revision 5 now complies with the requirements of the new "Variations Regulation" and can be viewed on the CMDh's website.

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In July 2025, the FDA inspected a US contract manufacturer of OTC drugs. The Warning Letter describes in particular the lack of physical separation, inadequate cleaning of shared equipment, and deficiencies in the quality system. To make matters worse, the FDA had already pointed out similar deficiencies in 2018.

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Back in August 2025, the US FDA inspected an Indian manufacturer of solid dosage forms and identified serious GMP deficiencies. The complaints relate in particular to inadequate investigations of quality defects in tablets, deficiencies in the cleaning of non-dedicated equipment and deficiencies in the cleaning validation programme.

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When it comes to supplier qualification, it is unfortunately still often forgotten that audits or audit reports are only one component of supplier qualification, albeit an important one. Read on to find out what else is involved.

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Annex 15 is about to become far more relevant for API manufacturers. Stronger requirements for deviation investigations and process understanding will raise the bar for quality oversight across the supply chain.

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