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FDA Quality Considerations for Continuous Manufacturing

This guidance provides information regarding FDA’s current thinking on the quality considerations for continuous manufacturing of small molecule, solid oral drug products that are regulated by the Center for Drug Evaluation and Research (CDER).

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Reflection paper on the qualification of non-genotoxic impurities

The core ICH quality guidelines addressing qualification of NGI are ICH Q3A and Q3B. These guidelines state that qualification is the process of acquiring and evaluating data that establishes the biological safety of an individual impurity or a given impurity profile at the level(s) specified

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Safety Features for Medicinal Products for Human Use

Answer: The safety features consist of two elements placed on the packaging of a medicinal product: (1) a unique identifier, a unique sequence carried by a two-dimensional barcode allowing the identification and authentication of the individual pack on which it is printed

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