GXP ACADEMY · USP GUIDELINES
Practical analysis of USP chapters and their application within the GMP system: compendial requirements, methods and testing, microbiology, packaging systems and lifecycle management. Built to define applicability, test plans, responsibilities, documentation and change control in a defensible way.
USP CHAPTERS · COMPENDIAL COMPLIANCE
Practical guides to requirements, testing, documentation and audit expectations. The collection starts with USP 382 and will progressively expand to other USP chapters.
A practical guide to USP <1225> Validation of Compendial Procedures: test categories, analytical performance characteristics, how it differs from <1226> verification, and the revision aligning the chapter with...
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USP and govern the microbiological examination of nonsterile products: enumeration (TAMC/TYMC) and tests for specified microorganisms. A practical comparison of the two chapters, method suitability requirements and USP...
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A practical guide to USP <85> endotoxin limits and the Bacterial Endotoxins Test: how the LAL method works (gel-clot, turbidimetric, chromogenic), how to calculate endotoxin limits and MVD,...
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USP <1790> Visual Inspection of Injections guides the visual inspection of injectable products: 100% inspection, AQL sampling, particle and defect classification, inspector qualification. Here is how to apply...
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How many units should you test, and how much product per medium? The USP sterility testing sample size explained through Tables 2 and 3: rules for parenterals, ophthalmics...
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A practical guide to USP Particulate Matter in Injections: what the chapter requires, the light obscuration and microscopic methods, the exact subvisible particle limits for SVP and LVP,...
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USP Analytical Instrument Qualification defines how to qualify laboratory analytical instruments: Groups A, B and C, the 4Q model (DQ, IQ, OQ, PQ) and responsibilities. A practical guide...
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USP 797 cleaning requirements in practice: Table 10 minimum frequencies for the PEC, surfaces and floors, the three required agents (cleaning agent, EPA-registered disinfectant, sporicidal) and the role of sterile...
USP 797 cleaning requirements in practice: Table 10 minimum frequencies for the PEC, surfaces and floors, the three required agents (cleaning agent, EPA-registered disinfectant, sporicidal) and the role of sterile...
A practical guide to USP <1225> Validation of Compendial Procedures: test categories, analytical performance characteristics, how it differs from <1226> verification, and the revision aligning the chapter with ICH Q2(R2)...
A practical guide to USP <1225> Validation of Compendial Procedures: test categories, analytical performance characteristics, how it differs from <1226> verification, and the revision aligning the chapter with ICH Q2(R2)...
USP and govern the microbiological examination of nonsterile products: enumeration (TAMC/TYMC) and tests for specified microorganisms. A practical comparison of the two chapters, method suitability requirements and USP acceptance criteria.
USP and govern the microbiological examination of nonsterile products: enumeration (TAMC/TYMC) and tests for specified microorganisms. A practical comparison of the two chapters, method suitability requirements and USP acceptance criteria.
A practical guide to USP <85> endotoxin limits and the Bacterial Endotoxins Test: how the LAL method works (gel-clot, turbidimetric, chromogenic), how to calculate endotoxin limits and MVD, and how...
A practical guide to USP <85> endotoxin limits and the Bacterial Endotoxins Test: how the LAL method works (gel-clot, turbidimetric, chromogenic), how to calculate endotoxin limits and MVD, and how...
USP <1790> Visual Inspection of Injections guides the visual inspection of injectable products: 100% inspection, AQL sampling, particle and defect classification, inspector qualification. Here is how to apply it together...
USP <1790> Visual Inspection of Injections guides the visual inspection of injectable products: 100% inspection, AQL sampling, particle and defect classification, inspector qualification. Here is how to apply it together...
How many units should you test, and how much product per medium? The USP sterility testing sample size explained through Tables 2 and 3: rules for parenterals, ophthalmics and bulk...
How many units should you test, and how much product per medium? The USP sterility testing sample size explained through Tables 2 and 3: rules for parenterals, ophthalmics and bulk...
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