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.
PIC/S has published draft guidelines for a new Annex 22: Artificial Intelligence. The proposal sets out a lifecycle-oriented framework for static, deterministic AI/ML models used in critical GMP...
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EMA’s Annex 22 work places adaptive, probabilistic and generative AI at the centre of a GMP control-strategy discussion. The final guidance is not yet available; manufacturers can nevertheless...
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The revised EU GMP Annex 19 becomes applicable on 24 September 2026. Its most material new provisions address reference and retention samples for parallel imported, parallel distributed and...
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EMA’s 2026–2027 pilot puts risk-based change management under practical inspection focus. For GMP leaders, the issue is no longer only whether the PQS is documented, but whether its...
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How to set up trend analysis and KPIs for deviations and CAPA: dashboards, thresholds, escalation, Management Review and PQS integration according to ICH Q9/Q10.
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A pragmatic 30-day checklist for veterinary medicinal-product and active-substance manufacturers to align their PQS, documents, roles and evidence with Commission Implementing Regulations (EU) 2025/2091 and 2025/2154.
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Recurrence does not automatically prove CAPA failure. Learn how to compare mechanisms, challenge root cause and verify effectiveness with inspection-defensible evidence.
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Annex 22 is not final EU GMP. Current Annex 11 remains the baseline. Here is a practical readiness framework for AI use cases in pharmaceutical manufacturing.
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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, 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.
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 manufacturers can...
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 manufacturers can...
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 manufacturers and...
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 manufacturers and...
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, the immediate...
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, the immediate...
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