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OOS Retest Calculator

L1/L2 deviation from label claim — retest units for content-uniformity screening.

Screen content-uniformity style results — L1/L2 deviation from label claim and typical retest unit count for batch investigation planning.

Results

L1 result

Pass

L2 result

Pass

Deviation

2.50%

Retest units

None

Sample mean 97.5% vs label claim 100.0% — deviation 2.50%. Within L1 (±15% of claim). No retest indicated at this screening stage. RSD 3.0% noted — confirm against method validation and compendial criteria.

infoCompendial planning aid. Compendial planning aid only — not a substitute for your validated SOP, pharmacopeial edition in force, regulatory submission, or qualified-person release decision. Always verify sampling tables against the official USP-NF (or applicable pharmacopeia) and your quality system before testing or batch disposition.

Need expert help?

Document OOS investigations in Pharma Quality Studio

Pharma Quality Studio helps you structure OOS/OOT investigations, CAPA links, and audit-ready batch disposition memos.

psychologySpecialist: Melody — Pharma & GMP

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OOS screening starts with limits — investigations need a system

When a batch mean drifts from label claim, QA applies L1 and L2 tolerance bands before deciding on retest or rejection. The math is simple; the documentation is not.

Retest consumes additional units and time — reserve sample and release timelines both move. Know the count before you pull from the batch.

This calculator supports screening only. Pharma Quality Studio carries the investigation narrative Melody helps QA teams draft for auditors.

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