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.

19 articles available

Pharmacopoeias

Illustrazione editoriale GuideGxP a colori sul tema GMP: la farmacopea messicana FEUM e il controllo qualità dei medicinali.

What Is the FEUM? Mexico's Pharmacopoeia Explained

What is the FEUM? The Farmacopea de los Estados Unidos Mexicanos explained: who writes it, why it is mandatory for the Mexican market and what changes with edition 14.0, in...

What Is the FEUM? Mexico's Pharmacopoeia Explained

What is the FEUM? The Farmacopea de los Estados Unidos Mexicanos explained: who writes it, why it is mandatory for the Mexican market and what changes with edition 14.0, in...

Illustrazione editoriale GuideGxP a colori sul tema GMP: accesso alla Farmacopea Europea online.

European Pharmacopoeia Online: Access, Editions...

Since 1 January 2026 the European Pharmacopoeia online is the only official format of the Ph. Eur. How the 12th Edition works with three annual issues, what the EDQM 365-day...

European Pharmacopoeia Online: Access, Editions...

Since 1 January 2026 the European Pharmacopoeia online is the only official format of the Ph. Eur. How the 12th Edition works with three annual issues, what the EDQM 365-day...

Illustrazione editoriale GuideGxP a colori sul tema GMP: acqua purificata in Farmacopea Europea, analista QC al punto d'uso di un loop di acqua farmaceutica.

Purified Water in the European Pharmacopoeia: L...

Purified water in the European Pharmacopoeia is governed by monograph 0008: conductivity, TOC and nitrate limits, microbiological requirements and the tests for water in containers. A practical guide to the...

Purified Water in the European Pharmacopoeia: L...

Purified water in the European Pharmacopoeia is governed by monograph 0008: conductivity, TOC and nitrate limits, microbiological requirements and the tests for water in containers. A practical guide to the...

Illustrazione editoriale GuideGxP a colori sul tema GMP: la Farmacopea Europea 12ª edizione online-only consultata da un analista QC in laboratorio.

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,...

Illustrazione editoriale GuideGxP a colori sul tema GMP: test di sterilità secondo farmacopea in laboratorio di microbiologia QC.

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...

Reference Standards GMP: qualifica, tracciabilità e scadenze (USP/Ph. Eur.)

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