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As we reported at the end of last year, China has revised its counter-espionage law. Now there are fears that this will also affect GMP inspections and audits, as the German Handelsblatt writes.

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A manufacturer of over-the-counter (OTC) drug products based in Canada received a Warning Letter from the U.S. Food and Drug Administration (FDA) regarding significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.

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The FDA's current approach to monitoring pharmaceutical manufacturing emphasises the importance of quality metrics in ensuring product safety and efficacy. What is behind this?

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The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to a Chinese manufacturer of over-the-counter (OTC) drug products. The violations were identified during the FDA's review of records submitted by the company in response to an official request.

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A sterile manufacturer in Jordan received a Warning Letter from the US FDA for inadequate equipment and facility design as well as other deficiencies.

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A court in the UK has sentenced a pharmaceutical company and its former director to heavy fines. The defendant had admitted to knowingly submitting falsified stability data to the MHRA in order to obtain a Marketing Authorization for a product. This was preceded by years of investigation by the authority.

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A recent EU Statement of Non-Compliance with GMP contains significant observations and requires the inspected company to carry out a detailed analysis, particularly with regard to CAPA.

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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a drug manufacturing facility in Thailand. The violations include failure to conduct appropriate laboratory testing for identity and strength of active ingredients prior to release and distribution.

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In February 2024, the ECA offered the Live Online Training "How to register APIs in Brazil - Focus on CADIFA and obtaining a Brazilian GMP certificate". During the Q&A sessions, many interesting questions were posed to the speakers' team. A list of useful abbreviations and definitions in regard on the Brazilian registration system are collected and provided in the following.

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A non-compliance report was issued by the inspecting Maltese authority following an inspection at an Indian pharmaceutical manufacturer. The inspection was the follow-up inspection to an inspection already carried out in 2022, which was intended to monitor the implementation of the measures. According to the authority, the remaining deficiencies and risks of cross-contamination were problematic.

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