Out-of-specification analytical results
Understand what an out-of-specification result means, what an investigation needs to establish and why a later passing result is not an explanation.
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Out-of-trend results within specification
Understand why a result can meet its acceptance limit yet warrant investigation when it departs from an established pattern.
Read the article →Retesting and resampling are different investigations
Understand which part of an analytical investigation changes when the same material is tested again or a new sample is collected.
Read the article →Conflicting purity and identity results
Understand how a strong purity result can coexist with an unresolved identity result, and how to frame the discrepancy for investigation.
Read the article →How to read a laboratory deviation statement
Read a recorded departure from a procedure by separating the event, its analytical impact, the investigation and corrective action.
Read the article →Unspecified impurities on peptide reports
Distinguish unspecified from unidentified impurities, interpret unnamed chromatographic peaks and recognise what their reported percentages cannot establish.
Read the article →Mass balance in peptide material characterisation
Understand how peptide, water, counterions and other components can be reconciled on a common mass basis, and what an apparently complete total can hide.
Read the article →Acceptance criteria should precede results
Understand why test limits and decision rules should be defined before judging a result, while distinguishing legitimate method development from moving a limit to obtain a pass.
Read the article →Analytical subcontracting and combined reports
Read reports that bring together tests from more than one laboratory by checking who performed each activity, which material was used and how qualifications were preserved.
Read the article →Documenting a quality concern with a supplier
Assemble a clear record of the product, lot, observation and supporting evidence so a supplier can investigate a material concern without guessing.
Read the article →Recovery-corrected and uncorrected assay results
Reconcile assay values before and after a stated recovery correction, and recognise when applying another correction would be misleading.
Read the article →Anhydrous, dried and as-received assay results
Understand how excluding measured water or drying loss changes an assay denominator without necessarily changing the target amount.
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