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These areas of enforcement focus include ineffective quality units , poor testing of incoming materials and components (i.e., relying on a suppliers certificate of analysis), poor product testing , poor analytical and microbial testing and validation methodology (including method suitability) , and inadequate nonconformance management

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A researcher might observe a negative outcome and incorrectly attribute it to the peptide itself when the real culprit is a solvent residue, a synthesis byproduct, or incorrect peptide sequencing