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GMP News

10 points on how the FDA's CDER monitors the Quality of Medicinal Products

The FDA's Center for Drug Evaluation and Research (CDER) has compiled a 10-point overview of how it fulfils its task of ensuring the quality of medicinal products. What are these 10 points?

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End Product Testing versus Process Validation

End product testing versus validation? This is a question that is frequently discussed in the GMP environment. The argument is that if the specification of the end product fits, which is even included in the marketing authorisation, then the process must also fit. Otherwise, no specification-compliant product would be manufactured. For the FDA this is a good example that this is not "state of the art".

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Testing of Medicinal Products is no Evidence against Cross-Contamination

During an FDA inspection of an Indian pharmaceutical manufacturer, residues were found in non-dedicated manufacturing equipment. The manufacturer had tried to rule out possible cross-contamination by testing retained samples. Read here why this is not sufficient for the FDA.

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