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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a South Korean manufacturer of OTC drug products. During an FDA laboratory testing of a batch of hand sanitizer, the impurity benzene at unacceptable levels was found. After a review of records and other information provided by the manufacturer, the FDA came to the conclusion that the quality assurance within the facility is not functioning in accordance with CGMP requirements.

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A pilot project will be launched under the auspices of ICMRA to conduct hybrid inspections at facilities of applicants.

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The United Kingdom (UK) becomes a full member of three international associations, including the International Council for Harmonisation ICH.

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Following the previously published list of documents needed during GCP inspections, the EMA issued a set of updated documents on planning and conducting GCP inspections on its website. The annexes compile specific items that may be verified at the sponsor / CRO / investigator site and clinical laboratories.  

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The EFPIA has published its "Annual Regulatory GMP/GDP Inspection Survey 2021 Data". With some interesting results that perhaps not everyone would have expected.

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In a Warning Letter addressed to a US-American pharmaceutical manufacturer, the FDA points out various deficiencies in aseptic production. Among other things, deficiencies are described in the design of equipment and rooms, airflow and visual inspection.

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The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched a pilot project for a new Compliance Monitor Process. External consultants are being used for this purpose.

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The U.S. Food and Drug Administration (FDA) has issued a warning letter to an American manufacturer of OTC drug products. Among others, the analytical test methods had not been validated for accuracy, specificity, and reproducibility. Further violations concern the process validation and OOS investigations.

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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to an American manufacturer. The firm produces a United States Pharmacopeia (USP) article. The core problem was that the company deviated from the USP for analytical testing, but could not adequately demonstrate that the method is equivalent or better than the current USP compendial method.

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The FDA is planning a programme to assess and classify manufacturing sites using surveillance data and company participation. A central point here is also the so-called Quality Culture.

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