Dissolution Testing: Practical Guide USP vs. Ph. Eur.
Apparatus, medium, degassing, sampling, and S1–S3 criteria: how to execute dissolution testing in an audit-ready way, USP and Ph. Eur.
Read the article →GXP ACADEMY · PHARMACOPOEIAS
Pharmacopoeias: turn compendial requirements into applicable controls.
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.
✓ USP · Ph. Eur. · Other compendia
✓ Methods · Monographs · Standards
✓ Multi-market · Audit readiness
PHARMACOPOEIAS · METHODS · STANDARDS
Manage compendial compliance systematically across markets.
Reference standards, method verification, bioassays, dissolution, OOS and audits addressed through practical criteria, examples and concrete control points.
GMP Storage of Reference Standards (RS): Inventory, Expiry Dates and FDA/EMA Audits
How to store and track Reference Standards in GMP: temperature/light/humidity control, expiry dates, usage logs, inventory and audit checklists.
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Pharmacopoeial Harmonisation (PDG): What Changes for USP, Ph. Eur., and JP (QC)
PDG and ICH Q4B explained operationally: harmonised chapters, allowed differences, how to avoid duplicate testing, and how to design SOPs and change control that stand up to audits.
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GMP Working Standard Qualification: Protocol, Assay Value and Retest Date
How to qualify and re-qualify a secondary standard: comparison vs primary, acceptance criteria, calculations, documentation and common pitfalls to avoid.
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GMP Audits and Pharmacopoeias: Defending USP vs. Ph. Eur. Decisions (QA/QC)
What FDA/EMA inspectors ask about USP/Ph. Eur. divergences and which evidence is required: dossiers, tables, risk assessments, comparability data, and response scripts.
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GMP Reference Standards: USP, Ph. Eur. and FDA/EMA Audits
How to manage RS / CRS / USP RS and Working Standards in GMP: types, traceability, compendial use, risks and inspection expectations.
Read the article →Pharmacopoeias
Dissolution Testing: Practical Guide USP vs. Ph...
Apparatus, medium, degassing, sampling, and S1–S3 criteria: how to execute dissolution testing in an audit-ready way, USP and Ph. Eur.
Dissolution Testing: Practical Guide USP vs. Ph...
Apparatus, medium, degassing, sampling, and S1–S3 criteria: how to execute dissolution testing in an audit-ready way, USP and Ph. Eur.
GMP Storage of Reference Standards (RS): Invent...
How to store and track Reference Standards in GMP: temperature/light/humidity control, expiry dates, usage logs, inventory and audit checklists.
GMP Storage of Reference Standards (RS): Invent...
How to store and track Reference Standards in GMP: temperature/light/humidity control, expiry dates, usage logs, inventory and audit checklists.
Pharmacopoeial Harmonisation (PDG): What Change...
PDG and ICH Q4B explained operationally: harmonised chapters, allowed differences, how to avoid duplicate testing, and how to design SOPs and change control that stand up to audits.
Pharmacopoeial Harmonisation (PDG): What Change...
PDG and ICH Q4B explained operationally: harmonised chapters, allowed differences, how to avoid duplicate testing, and how to design SOPs and change control that stand up to audits.
GMP Working Standard Qualification: Protocol, A...
How to qualify and re-qualify a secondary standard: comparison vs primary, acceptance criteria, calculations, documentation and common pitfalls to avoid.
GMP Working Standard Qualification: Protocol, A...
How to qualify and re-qualify a secondary standard: comparison vs primary, acceptance criteria, calculations, documentation and common pitfalls to avoid.
GMP Audits and Pharmacopoeias: Defending USP vs...
What FDA/EMA inspectors ask about USP/Ph. Eur. divergences and which evidence is required: dossiers, tables, risk assessments, comparability data, and response scripts.
GMP Audits and Pharmacopoeias: Defending USP vs...
What FDA/EMA inspectors ask about USP/Ph. Eur. divergences and which evidence is required: dossiers, tables, risk assessments, comparability data, and response scripts.
GMP Reference Standards: USP, Ph. Eur. and FDA/...
How to manage RS / CRS / USP RS and Working Standards in GMP: types, traceability, compendial use, risks and inspection expectations.
GMP Reference Standards: USP, Ph. Eur. and FDA/...
How to manage RS / CRS / USP RS and Working Standards in GMP: types, traceability, compendial use, risks and inspection expectations.
