생명과학 eQMS 16개 항목
Bacterial Endotoxin (LAL) Testing Checklist (USP <85>)
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Confirms that bacterial endotoxin testing by the Limulus Amebocyte Lysate (LAL) method is properly validated, controlled, and interpreted for injectable products and medical devices. Use to establish or audit an endotoxin testing program.
USP <85>21 CFR 211.167USP <161>
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Endotoxin Limit and Method
- Is the endotoxin limit calculated using the product-specific K/M formula and threshold pyrogenic dose? *
- Is the LAL method selected (gel-clot, turbidimetric, or chromogenic) documented with rationale? *
- Record the calculated endotoxin limit (EU/mL or EU/mg).
- Is the maximum valid dilution (MVD) calculated and applied? *
Reagent and Standard Control
- Is the LAL reagent labeled sensitivity (lambda) confirmed on receipt and before use? *
- Is the Reference Standard Endotoxin (RSE) or Control Standard Endotoxin (CSE) traceable and correctly reconstituted? *
- Is LAL Reagent Water confirmed to be endotoxin-free (below detection limit)? *
- Is depyrogenated glassware or certified pyrogen-free labware used throughout? *
Validation - Inhibition and Enhancement
- Is the test for interfering factors (inhibition/enhancement) performed for each product? *
- Is spike recovery within 50-200% at the non-interfering dilution? *
- Is a positive product control (PPC) included in every routine test? *
- Are the standard curve correlation coefficient criteria met for photometric methods (|r| >= 0.980)? *
Test Execution and Disposition
- Are gel-clot positive and negative controls valid before accepting results? *
- Is the geometric mean endpoint used to confirm labeled lysate sensitivity for gel-clot?
- Are results below the endotoxin limit required for lot release of injectables? *
- Are failing or invalid tests investigated before any retest? *
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