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The competent authority of Czechia has added a new GPD Non-Compliance Report into the EudraGMDP database. The report states that the company concerned does not provide approved storage facilities and the services of a qualified person are not ensured.

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During various ECA training courses, the question came up who actually issues a GDP certificate and which companies can obtain such a document.

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In August 2021, the MHRA provided information on its website about GMP requirements and most common deficiencies in the area of "transfer of analytical methods".

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Deviations and CAPA are still important issues during inspections. Inspectors' summaries of their observations show that things do not always work as they should. This also applies to root cause investigations.

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Even though the USP has no direct force of law, certainly not in Europe, interesting points for use in risk-based supplier qualification programmes can be found in a newly proposed USP chapter.

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In May 2021, the U.S. FDA issued a Warning Letter to a Turkish over-the-counter (OTC) drug manufacturer called "Gulsah Uretim Kozmetik Sanayi Anonim Sirketi" due to significant violations of cGMP regulations for drug products.

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The United States Food and Drug Administration (FDA) has recently published a Warning Letter sent to an Australian manufacturer of over-the-counter (OTC) drug products. The Warning Letter summarizes significant violations of current good manufacturing practice (CGMP) concerning finished drug product testing, identity testing of active pharmaceutical ingredients (APIs), and stability testing.

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In a recently published Warning Letter sent to a Chinese company, the FDA criticises, among other aspects, that analytical test methods were not adequately validated and no system suitability requirements were present.

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The U.S. Food and Drug Administration (FDA) has purchased different products intended for sexual enhancement and weight loss offered for sale on amazon's website. In subsequent laboratory analysis, it was determined that all tested products contain undeclared and potentially harmful drug ingredients. In a letter dated July 26, 2021, sent to Amazon CEO Andy Jassy, the FDA requires Amazon to take measures to prevent such violations in the future.

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Are you familiar with a "non-paper"? This is the name given by the EU Commission to a new document that describes proposed solutions for the practical handling of problems within the framework of the Northern Ireland Protocol.

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