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GXP ACADEMY · PHARMACOPOEIAS
Practical analysis of the USP, European Pharmacopoeia and other compendia: monographs, methods, reference standards, bioassays, dissolution, OOS and change control. Built to manage differences across markets, verify methods and keep the Pharmaceutical Quality System aligned with updates.
PHARMACOPOEIAS · METHODS · STANDARDS
Reference standards, method verification, bioassays, dissolution, OOS and audits addressed through practical criteria, examples and concrete control points.
The USP sterility test (harmonised with Ph. Eur. 2.6.1) verifies the absence of viable microorganisms in sterile products. A practical guide to methods, culture media, incubation, sample size...
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QA/QC system to manage primary standards and working standards: qualification, logbook, storage, expiry, and pharmacopoeial change control
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Why Biological Assays Are “Critical” in FDA/EMA Inspections and How to Manage Them: Verification/Validation, Run Validity Criteria, Trending, and CAPA in a Lifecycle Approach
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When a failure is OOS, what to check in Phase I/II, defensible retest, CAPA, and documentation for FDA/EMA audits.
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Practical protocol for verifying compendial methods: minimum parameters, acceptance criteria, dossier structure, inspection red flags, and ready answers
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What “compendial” really means, when it is mandatory, how to perform method verification, and how to manage change control, QA/QC/QP responsibilities, and multi-market compliance.
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The USP sterility test (harmonised with Ph. Eur. 2.6.1) verifies the absence of viable microorganisms in sterile products. A practical guide to methods, culture media, incubation, sample size and the...
The USP sterility test (harmonised with Ph. Eur. 2.6.1) verifies the absence of viable microorganisms in sterile products. A practical guide to methods, culture media, incubation, sample size and the...
QA/QC system to manage primary standards and working standards: qualification, logbook, storage, expiry, and pharmacopoeial change control
QA/QC system to manage primary standards and working standards: qualification, logbook, storage, expiry, and pharmacopoeial change control
Why Biological Assays Are “Critical” in FDA/EMA Inspections and How to Manage Them: Verification/Validation, Run Validity Criteria, Trending, and CAPA in a Lifecycle Approach
Why Biological Assays Are “Critical” in FDA/EMA Inspections and How to Manage Them: Verification/Validation, Run Validity Criteria, Trending, and CAPA in a Lifecycle Approach
When a failure is OOS, what to check in Phase I/II, defensible retest, CAPA, and documentation for FDA/EMA audits.
When a failure is OOS, what to check in Phase I/II, defensible retest, CAPA, and documentation for FDA/EMA audits.
Practical protocol for verifying compendial methods: minimum parameters, acceptance criteria, dossier structure, inspection red flags, and ready answers
Practical protocol for verifying compendial methods: minimum parameters, acceptance criteria, dossier structure, inspection red flags, and ready answers
What “compendial” really means, when it is mandatory, how to perform method verification, and how to manage change control, QA/QC/QP responsibilities, and multi-market compliance.
What “compendial” really means, when it is mandatory, how to perform method verification, and how to manage change control, QA/QC/QP responsibilities, and multi-market compliance.
PRACTICAL GMP TOOLS FOR PHARMA
GuideGxP turns complex GMP requirements into operational guides, editable templates and practical insights for pharmaceutical professionals.
