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.
USP 788 vs 789: what really changes between subvisible particulate testing of injections and of ophthalmic solutions. Scope, light obscuration and microscopic methods, side-by-side limits and the 2026...
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USP <41> Balances defines the mandatory repeatability and accuracy requirements for balances whenever a material must be accurately weighed. This guide explains how to determine the operational minimum...
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USP 797 vs USP 800: the first protects the sterility of the preparation, the second protects workers and the environment from hazardous drugs. A complete comparison of goals,...
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USP Chromatography: what the general chapter covers, system suitability requirements and the adjustments allowed to compendial methods without revalidation. A practical guide to the version harmonized with Ph....
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USP and define the characterization of plastic materials and the qualification of pharmaceutical packaging systems, official since December 1, 2025. A practical guide to both chapters, the no-grandfathering...
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The FDA draft guidance on container closure systems (August 2026) supersedes the 1999 guidance and the 2002 Q&A. Risk-based framework by dosage form, CCIT, extractables & leachables and...
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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...
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USP 788 vs 789: what really changes between subvisible particulate testing of injections and of ophthalmic solutions. Scope, light obscuration and microscopic methods, side-by-side limits and the 2026 harmonized revision.
USP 788 vs 789: what really changes between subvisible particulate testing of injections and of ophthalmic solutions. Scope, light obscuration and microscopic methods, side-by-side limits and the 2026 harmonized revision.
USP <41> Balances defines the mandatory repeatability and accuracy requirements for balances whenever a material must be accurately weighed. This guide explains how to determine the operational minimum weight and...
USP <41> Balances defines the mandatory repeatability and accuracy requirements for balances whenever a material must be accurately weighed. This guide explains how to determine the operational minimum weight and...
USP 797 vs USP 800: the first protects the sterility of the preparation, the second protects workers and the environment from hazardous drugs. A complete comparison of goals, scope, facility...
USP 797 vs USP 800: the first protects the sterility of the preparation, the second protects workers and the environment from hazardous drugs. A complete comparison of goals, scope, facility...
USP Chromatography: what the general chapter covers, system suitability requirements and the adjustments allowed to compendial methods without revalidation. A practical guide to the version harmonized with Ph. Eur. 2.2.46,...
USP Chromatography: what the general chapter covers, system suitability requirements and the adjustments allowed to compendial methods without revalidation. A practical guide to the version harmonized with Ph. Eur. 2.2.46,...
USP and define the characterization of plastic materials and the qualification of pharmaceutical packaging systems, official since December 1, 2025. A practical guide to both chapters, the no-grandfathering transition and...
USP and define the characterization of plastic materials and the qualification of pharmaceutical packaging systems, official since December 1, 2025. A practical guide to both chapters, the no-grandfathering transition and...
The FDA draft guidance on container closure systems (August 2026) supersedes the 1999 guidance and the 2002 Q&A. Risk-based framework by dosage form, CCIT, extractables & leachables and combination products:...
The FDA draft guidance on container closure systems (August 2026) supersedes the 1999 guidance and the 2002 Q&A. Risk-based framework by dosage form, CCIT, extractables & leachables and combination products:...
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