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As previously reported, China has revised its counter-espionage law. The issue is currently attracting increasing international attention and has now also been taken up by the Financial Times. Several rejections of inspections and one arrest have already been reported.

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At the beginning of April, the FDA published a Warning Letter to a manufacturer from South Korea. This contained a whole series of deficiencies, including a lack of validation of manufacturing processes and quality control measures, as well as a lack of testing of ingredients such as glycerine for the absence of ethylene and diethylene glycol.

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The "Best practices guide for managing suppliers of API manufacturers" was finalised by the "APIC Supplier Management Task Force" in March 2024 and is now available on the APIC website. It emerged from the document "Supplier Qualification and Management Guideline", which was first published in 2009, and now replaces it in its entirety.

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On 09 April 2024, a new FDA Form 483 to a company in India was published. The document lists a total of 10 observations made by the FDA investigators during the inspection in March 2024 of the firm's facility located in Baddi.

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Since 2022, the series of Warning Letters, but also the activities of the authorities on the subject of testing for ethylene and diethylene glycol, has not stopped. The FDA recently published another Warning Letter.

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In April 2024, the U.S. FDA issued a Warning Letter on its webpage to the Australian company "Antaria Pty. Ltd." after having inspected its site in November 2023. According to the Warning Letter the company missed to have an appropriate stability program for its API in place.

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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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