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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Mexican manufacturer. According to the FDA, the firm did not adequately validate the process and qualify the equipment used to manufacture the drug products. Furthermore, the company did not adequately test components prior to use in the manufacture of drug products destined for the US market.

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Swissmedic inspections may be carried either out on-site, (partly) by means of remote assessments or at a later point in time.

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The updated version of the paperback "ICH Q7 Side-by-Side Comparison", which lists and compares the "ICH Q7 Guideline - GMP for Active Pharmaceutical Ingredients" with the "How to do"- Document - Interpretation of ICH Q7 Guide and "Review form" on GMPs for APIs, is now available.

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Due to the deficiencies identified during an inspection that the FDA had already conducted in February 2020, an Indian pharmaceutical manufacturer has now received a Warning Letter. The main reasons for this were deficiencies in equipment design, validation and incoming goods inspection. Read more here.

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A repacker in the US has recently received a Warning Letter from the FDA. The described deficiencies are repackaging of products in non-equivalent primary packaging, the lack of cleaning validation and the establishment of a suitable quality unit.

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The British MHRA has joined an Australia-Canada-Singapore-Switzerlan Consortium to explore opportunities for information and work-sharing.

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A US-American pharmaceutical manufacturer has recently received a Warning Letter from the FDA due to deficiencies in packaging and quality assurance.

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FDA's Office of Regulatory Affaires (ORA) is publishing electronic copies of various inspection and related records on their websites.

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A Warning Letter was sent to a company who shipped product without a release.

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Roughly 10% of deficiencies raised by MHRA inspectors were directly attributable to poor investigations. So what do inspectors observe?

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