Skip-Lot Testing
Reducing test frequency on a stable product/supplier after a clean history - with documented justification.
Skip-lot testing is a risk-based program that reduces how often you run certain tests - say, every 3rd or 5th batch instead of every batch - once you've built a documented history of clean results from the same supplier and process.
It's legitimate under GMP, but only with a written statistical justification. Identity and potency typically stay on every batch; heavy metals and microbial are the usual candidates to reduce after 5-10 consecutive passes. Skip the justification and an investigator reads it as a gap.
Related terms
Guides that cover Skip-Lot Testing
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