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A recent FDA Warning Letter highlights GMP violations at a U.S. manufacturer of over-the-counter (OTC) drug products, including missing microbiological testing, lack of stability data, and inadequate raw material controls.

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The EFPIA has published its "Annual Regulatory GMP/GDP Inspection Survey 2024 Data", containing some interesting results that not everyone may have expected.

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Malta's Medicines Authority recently issued two GMP non-compliance statements: One to a manufacturer of cannabis-based medicinal products and another to a Quality Control testing laboratory for the analytical testing of non-sterile dosage forms (specifically for medical Cannabis products).

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Find out what the GMP Auditor Association was working on and accomplished in the first four months of 2025 - in the latest report.

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In May 2025, the IPEC International Pharmaceutical Excipients Council Europe (IPEC Europe) announced the new Version 1 of its “IPEC Risk Assessment Guide for Pharmaceutical Excipients - Risk Assessment for Excipient Manufacturers (Version 1, 2025)” on its website.

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A recent FDA Warning Letter reveals severe GMP breaches at a U.S. drug manufacturer, including the absence of written procedures, reliance on undocumented processes, and a failure to perform basic analytical testing such as identity, strength, and microbiological checks prior to product release.

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The FDA inspection of the US manufacturer of OTC products already took place in January 2025. The FDA criticized laboratory tests, missing microbiological specifications and the Quality Unit, which had not fulfilled its responsibilities. The water system in particular also showed serious deficiencies. Read more.

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The Q&A document "Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products", which was prepared jointly by the EMA and the CMDh, has been updated once again and published in the new revision 22 on the EMA website.

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A US company received a Warning Letter because of problems at their CMO. FDA points out that companies should have a robust qualification process for CMOs.

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The guideline 'Additional guidance on the assessment on the risk assessment for presence of N-nitrosamines in APIs', first published in February 2020, has now been revised by a subgroup of the 'APIC Nitrosamines Task Force' and recently published in its latest version on the APIC website. The document is now called 'Nitrosamine Risk Management: Guidance for API Manufacturers' and has been extensively updated.

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