EMA Annex 22 and AI in GMP: What Applies Today—and How to Prepare
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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From GxP requirements to stronger quality systems.
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.
✓ EU GMP · FDA · ICH
✓ Audits and inspections
✓ Applicable methods
ANALYSIS & PRACTICAL GUIDES
Insights that turn compliance into action.
Quality systems, audit readiness and GMP processes explained through concrete criteria, examples and practical points of attention.
GMP Internal Audit Report and CAPA: Writing Defensible Findings and Closing Them Properly
How to write a GMP internal audit report with clear and defensible findings, classify Critical/Major/Minor, define robust CAPA and perform effectiveness checks. Includes ready-to-use templates and an “inspection...
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VMP in FDA/EMA Audits: How to Present It, Answer Questions and Prevent Findings
Practical checklist to defend the VMP during inspection: typical questions, how to prepare the war room, errors that generate findings and how to manage gaps.
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GMP CAPA: How to Design Them and Demonstrate Their Effectiveness
Audit-proof CAPA: difference between correction/corrective/preventive action, design from root cause, change control, evidence completion and effectiveness check.
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How to Conduct a GMP Internal Audit: Checklist, Interviews, Evidence and Meeting
Practical guide to conducting a GMP internal audit: audit plan and checklist, opening meeting, effective questions, evidence collection, time management and closing meeting. With ready-to-use examples.
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Extractables & Leachables: Practical Risk Assessment (ICH Q9)
Risk-based method to decide when E&L studies are required. Matrix, examples, audit-defensible criteria and focus on inspection expectations.
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GMP Deviation Management: Audit-Proof Process (EU GMP/FDA)
How to manage GMP deviations in an audit-proof way: reporting, containment, classification, impact assessment, investigation and closure without red flags.
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Risk-Based GMP Internal Audit Programme: An “Inspection-Ready” Annual Plan
How to build a risk-based annual GMP internal audit programme according to ICH Q9/Q10: audit universe, risk matrix, frequencies, independent auditors, KPIs and ready-to-use templates.
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EMA Annex 22: Preparing GMP Manufacturing for P...
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 prepare a...
EMA Annex 22: Preparing GMP Manufacturing for P...
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 prepare a...
EudraLex Volume 4 Annex 19 revised: preparing f...
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 parallel traded...
EudraLex Volume 4 Annex 19 revised: preparing f...
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 parallel traded...
EMA PQS effectiveness pilot: moving from docume...
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 operation can...
EMA PQS effectiveness pilot: moving from docume...
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 operation can...
Deviation & CAPA Trend Analysis: KPIs and QRM (...
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.
Deviation & CAPA Trend Analysis: KPIs and QRM (...
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.
Veterinary GMP from 16 July 2026: an operationa...
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.
Veterinary GMP from 16 July 2026: an operationa...
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.
When a Deviation Returns: Challenge the CAPA, N...
Recurrence does not automatically prove CAPA failure. Learn how to compare mechanisms, challenge root cause and verify effectiveness with inspection-defensible evidence.
When a Deviation Returns: Challenge the CAPA, N...
Recurrence does not automatically prove CAPA failure. Learn how to compare mechanisms, challenge root cause and verify effectiveness with inspection-defensible evidence.
