European Pharmacopoeia 12th Edition: What Changes
The European Pharmacopoeia 12th Edition moves to an online-only format with three issues per year and fixed application dates in January, April and July. Here is what changes...
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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.
USP <71> Sterility Tests and Ph. Eur. 2.6.1: Practical Guide
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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GMP Reference Standards: Qualification, Traceability, and Expiry Management (USP/Ph. Eur.)
QA/QC system to manage primary standards and working standards: qualification, logbook, storage, expiry, and pharmacopoeial change control
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Compendial bioassays in GMP: validation and variability control (audit-ready)
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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OOS in Dissolution: GMP Investigation and Retest
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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Method Verification USP/Ph. Eur.: GMP Guide for QC and QA
Practical protocol for verifying compendial methods: minimum parameters, acceptance criteria, dossier structure, inspection red flags, and ready answers
Read the article →Pharmacopoeias
European Pharmacopoeia 12th Edition: What Changes
The European Pharmacopoeia 12th Edition moves to an online-only format with three issues per year and fixed application dates in January, April and July. Here is what changes for QA,...
European Pharmacopoeia 12th Edition: What Changes
The European Pharmacopoeia 12th Edition moves to an online-only format with three issues per year and fixed application dates in January, April and July. Here is what changes for QA,...
USP <71> Sterility Tests and Ph. Eur. 2.6.1: Pr...
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...
USP <71> Sterility Tests and Ph. Eur. 2.6.1: Pr...
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...
GMP Reference Standards: Qualification, Traceab...
QA/QC system to manage primary standards and working standards: qualification, logbook, storage, expiry, and pharmacopoeial change control
GMP Reference Standards: Qualification, Traceab...
QA/QC system to manage primary standards and working standards: qualification, logbook, storage, expiry, and pharmacopoeial change control
Compendial bioassays in GMP: validation and var...
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
Compendial bioassays in GMP: validation and var...
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
OOS in Dissolution: GMP Investigation and Retest
When a failure is OOS, what to check in Phase I/II, defensible retest, CAPA, and documentation for FDA/EMA audits.
OOS in Dissolution: GMP Investigation and Retest
When a failure is OOS, what to check in Phase I/II, defensible retest, CAPA, and documentation for FDA/EMA audits.
Method Verification USP/Ph. Eur.: GMP Guide for...
Practical protocol for verifying compendial methods: minimum parameters, acceptance criteria, dossier structure, inspection red flags, and ready answers
Method Verification USP/Ph. Eur.: GMP Guide for...
Practical protocol for verifying compendial methods: minimum parameters, acceptance criteria, dossier structure, inspection red flags, and ready answers
