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The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has published two guidance documents for GDP inspectors, an Aide-Memoire on GDP inspections and a Q&A document. Both documents entered into force on 01 February 2023.

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Due to numerous and fundamental GMP deficiencies, the FDA has issued a Warning Letter to a manufacturer of over-the-counter antibacterial hand soap, antiseptics and hand sanitizer in Puerto Rico.

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The U.S. Food and Drug Administration (FDA) has once again published a Warning Letter to a US manufacturer of hand sanitizers. During an inspection, several CGMP violations were found. In addition to inadequate release testing in general, the finished products are likely to be contaminated with methanol.

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The U.S. Food and Drug Administration (FDA) sent a Warning Letter to a drug manufacturer in Istanbul. During an inspection, several CGMP violations were found. Among other things, this concerns identity testing of incoming components, process validation and stability testing.

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A Slovakian company has its GMP certificate withdrawn after an inspection. The Qualified Person (QP) was also mentioned.

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A federal court has entered a consent decree of permanent injunction against a Florida-based drug importer and distributor. It prohibits the company from distributing active pharmaceutical ingredients (APIs) not manufactured, processed, or held in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). This was preceded by a legal dispute with the U.S. Food and Drug Administration (FDA).

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In January you could read about the publication of the revised ICH Q9 guideline. What is new with regard to quality risk management (QRM)?

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FDA sends warning letter to the manufacturer of a homeopathic honey product, among other things because of microbiological contamination with Bacillus spec. Due to the advertised use for children, there was a not insignificant risk..

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In May 2022, the US FDA inspected an Indian sterile manufacturer, revealing numerous deficiencies that have now led to a Warning Letter. Among other things, deficiencies in media fill, plant and cleanroom design, and environmental monitoring were cited.

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The U.S. Food and Drug Administration (FDA) has published two Warning Letters to manufactures of hand sanitizer drug products. In both cases, acetaldehyde and acetal impurities at unacceptable levels were found in several lots. The agency is concerned, because acetaldehyde is considered to be genotoxic, and potentially carcinogenic.

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