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Judgment & ambiguity · When to escalate

A long-qualified excipient supplier is showing a slow slide — more minor complaints, slower CAPA responses, a recent audit observation — none disqualifying on its own. Production depends on them and there's no second source. When do you escalate to dual-sourcing or de-qualification?

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I escalate the moment the pattern becomes a trend rather than a run of unrelated events — and slower CAPA responses plus rising complaints plus an audit observation, together, is a trend.

The full answer: structure, worked example, likely follow-up.

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