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.
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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Operational checklist to face GMP audits on USP/Ph. Eur.: inspected areas, red flags, audit package, mock inspection, and defensible CAPAs
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How to reconcile ICH Q3A/Q3B/Q3C/Q3D/M7 with Ph. Eur. and USP without audit risks in FDA/EMA inspections. Decision tree, examples and checklists.
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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
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.
Operational checklist to face GMP audits on USP/Ph. Eur.: inspected areas, red flags, audit package, mock inspection, and defensible CAPAs
Operational checklist to face GMP audits on USP/Ph. Eur.: inspected areas, red flags, audit package, mock inspection, and defensible CAPAs
How to reconcile ICH Q3A/Q3B/Q3C/Q3D/M7 with Ph. Eur. and USP without audit risks in FDA/EMA inspections. Decision tree, examples and checklists.
How to reconcile ICH Q3A/Q3B/Q3C/Q3D/M7 with Ph. Eur. and USP without audit risks in FDA/EMA inspections. Decision tree, examples and checklists.
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