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The PIC/S has published a draft Recommendation on risk-based change management within the PQS.

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In September, a US pharmaceutical manufacturer received a Warning Letter from the FDA due to GMP violations in the areas of equipment cleaning, drug stability and handling complaints.

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PIC/S hat einen Entwurf zu einer sog. Recommendation (Empfehlung) zum risikobasierten Change Management innerhalb der PQS veröffentlicht.

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Production and laboratory processes are for sure still a hot topic in inspections. But investigators are also focusing on the role of the Quality Unit and Quality Oversight.

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FDA's Warning Letters provide a valuable source of detailed information and can be helpful in preparing for an inspection, making a more detailed analysis worthwhile. Read more here about what FDA inspectors have discovered in recent months regarding frequent weaknesses at GMP-liable pharmaceutical manufacturers.

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Deviations and CAPAs are still hotly debated topics in GMP inspections. This is shown once again by a recent FDA Warning Letter.

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Besides several Quality Unit related failures, a Warning Letter of the U.S. FDA mentions an enormous number of Data Integrity violations. Here you can read the remedations expected by the FDA.

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Once again, an Indian pharmaceutical manufacturer has received a Warning Letter from the US-American FDA due to deficiencies discovered during an inspection. The Letter focuses on deficiencies in the validation and the handling of OOS results in the laboratory. Read more here

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According to the U.S. FDA, the Chinese firm failed to establish an adequate quality system and lacks quality oversight on documentation.

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Quite a few authorities in the health care sector come for GMP inspections, also to foreign countries. Here you can read what the Brazilian ANVISA will expect.

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