FDA Warning Letter: Serious GMP violations at US pharmaceutical manufacturers

Berlin, 30.04.2019 (PresseBox) – The FDA has recently issued another warning letter to a US pharmaceutical manufacturer describing serious GMP violations. This concerns the water system, the QC laboratory and quality assurance.
According to the FDA, the manufacturer is not in a position to produce water suitable for drug manufacturing that at least meets the requirements of USP Purified Water (aqua purificata). The high and multiple bacterial count exceedances at various points in the water system used for the production of oral liquid pharmaceuticals are extremely problematic.
In the area of quality control, the FDA criticises the inadequate validation of methods. For example, the recovery of a pathogenic germ found in the water system was not validated. In addition, the manufactured products are not tested for impurities in accordance with USP.
Quality assurance is also affected by deficiencies. For example, an unnamed substance was added during the manufacture of a batch without any change to the manufacturing documentation, stability studies or QA approval. The FDA thus questions the company’s change control procedure as well as the Annual Product Review System.
Another case concerns the QA oversight of the manufacturing process. For example, if the content of a product was too high, the pharmaceutical company corrected this by longer mixing times or adding water, for example, without validating this process. This means that neither the initial mixing process nor the dilution process are validated.
In another case, the manufacturer had received a complaint from the market about the smell of a product. The FDA regards the processing of the CAPA as insufficient. The company had indicated an improperly cured product container as the cause, but judged the product to be safe. However, the company does not have any data as to whether this is the case over the entire shelf life.
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