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GXP ACADEMY · GXP INSIGHTS
Practical analysis of GMP, Pharmaceutical Quality Systems, deviations, CAPA, change control, audits and risk management. Built to support sound interpretation, defensible decisions and stronger evidence.
ANALYSIS & PRACTICAL GUIDES
Quality systems, audit readiness and GMP processes explained through concrete criteria, examples and practical points of attention.
A practical GMP–pharmacovigilance governance model for assigning decision rights, escalating evidence and coordinating authority communications when a quality defect may affect patient safety.
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A practical, inspection-ready guide to controlling GMP records across paper, electronic and hybrid systems, using current EU GMP Chapter 4 as the baseline.
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A practical, non-statistical analysis of recurring CGMP failure themes illustrated by selected FDA Warning Letters published in 2026, with audit questions and CAPA design actions.
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A practical lifecycle guide to process validation in pharma, covering process design, PPQ, continued process verification and Annex 15 alignment.
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The TGA consultation on increasing transparency of GMP inspection outcomes closed on 13 July 2026. While no outcome should be assumed until the TGA publishes its decision, pharmaceutical...
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PIC/S has issued a corrigendum to the joint EMA–PIC/S concept paper on revising Annex 15: Qualification and Validation. The proposed revision would extend Annex 15 to active substance...
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EMA’s Annex 22 workshop does not create new GMP requirements, but it makes the likely evidence burden for adaptive, probabilistic and generative AI much clearer. For pharmaceutical manufacturers,...
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Since 16 July 2026, Commission Implementing Regulations (EU) 2025/2091 and (EU) 2025/2154 have applied directly across EU Member States. Their technical content is closely aligned with EU GMP...
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A practical framework for MAHs to assess, appoint, transition and govern an outsourced QPPV provider without losing pharmacovigilance control.
A practical framework for MAHs to assess, appoint, transition and govern an outsourced QPPV provider without losing pharmacovigilance control.
A practical, inspection-ready approach to planning, running, calculating and defending cleanroom particle-recovery testing under ISO 14644-3 and EU GMP Annex 1.
A practical, inspection-ready approach to planning, running, calculating and defending cleanroom particle-recovery testing under ISO 14644-3 and EU GMP Annex 1.
A practical GMP–pharmacovigilance governance model for assigning decision rights, escalating evidence and coordinating authority communications when a quality defect may affect patient safety.
A practical GMP–pharmacovigilance governance model for assigning decision rights, escalating evidence and coordinating authority communications when a quality defect may affect patient safety.
A practical, inspection-ready guide to controlling GMP records across paper, electronic and hybrid systems, using current EU GMP Chapter 4 as the baseline.
A practical, inspection-ready guide to controlling GMP records across paper, electronic and hybrid systems, using current EU GMP Chapter 4 as the baseline.
A practical, non-statistical analysis of recurring CGMP failure themes illustrated by selected FDA Warning Letters published in 2026, with audit questions and CAPA design actions.
A practical, non-statistical analysis of recurring CGMP failure themes illustrated by selected FDA Warning Letters published in 2026, with audit questions and CAPA design actions.
A practical lifecycle guide to process validation in pharma, covering process design, PPQ, continued process verification and Annex 15 alignment.
A practical lifecycle guide to process validation in pharma, covering process design, PPQ, continued process verification and Annex 15 alignment.
PRACTICAL GMP TOOLS FOR PHARMA
GuideGxP turns complex GMP requirements into operational guides, editable templates and practical insights for pharmaceutical professionals.
