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When conducting GDP audits, it can be helpful to work with question lists. We have compiled typical questions for ocean freight operations.

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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to an over-the-counter (OTC) drug product manufacturer in Los Angeles. Several GMP violations were identified in the area of laboratory testing, stability program, and quality oversight. In a previous inspection in 2018, similar observations were made. Therefore, the FDA considers the executive management oversight and control over the manufacture of drug products as inadequate.

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Inspections are a regulatory requirement in the GMP environment. This also applies to the USA. But what happens if a manufacturer simply refuses to permit a GMP inspection?

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In June 2022, the U.S. FDA issued a Warning Letter (WL) to the Spanish company "Bioiberica, SAU" after having inspected its site in January and February 2022.

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The FDA would like to use so-called Remote Regulatory Assessments (RRAs) not only during the COVID-19 pandemic, but also beyond it for the asessments of establishments and applications and has published a Draft Guidance for Industry on this.

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In June 2022, the U.S. FDA issued a Warning Letter tto the Dutch company "Fagron Group B.V." after having inspected their US American site "Fagron Inc." in November 2021.

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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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