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The FDA has recently published a Warning Letter following an inspection conducted at a US-American manufacturer of ophthalmic sterile preparations, which revealed numerous serious deficiencies. These include environmental monitoring, lab data integrity, gowning procedures, media fill and maintenance/cleaning of production equipment.

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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a US-based drug maker for significant violations of current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, including the failure to investigate out-of-specification (OOS) test results and to follow proper documentation practices.

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The classification defines, among other points, which kind of GMP certification is needed for export / import of Cannabis Flower to the EU and Germany.

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The UK Medicines and Healthcare products Regulatory Agency (MHRA) has recently published a post on temporary changes in Good Distribution Practice (GDP) in the MHRA Inspectorate Blog.

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TGA has published a media release stating that they have started to undertake "remote and/or hybrid GMP domestic inspections" in place of on-site inspections.

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Despite the MRA, FDA is still coming to the EU to inspect. Now a company from Bulgaria received a Warning Letter and was placed on Import Alert.

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The FDA has recently issued a Warning Letter to a large Indian pharmaceutical manufacturer following an inspection that revealed poor cleaning and later detected cross-contamination in manufactured tablets. Further GMP violations were detected like leaking HEPA filters and inadequate smoke studies in the sterile area.

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EMA, EC and HMA have created a Q&A document on regulatory expectations during the covid-19 pandemic. New questions and answers are dealing with remote audits and remote release.

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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Romania-based manufacturer of an unapproved new drug due to, among others, releasing drug products without conducting identity and strength testing.

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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Danish drugmaker for serious GMP violations, including inadequate testing of finished products. Furthermore, the company failed to conduct at least one test to verify the identity of each component of a drug product.

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