GXP ACADEMY · GXP INSIGHTS

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.

Explore the insights → Back to GxP Academy
✓ 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.

54 articles available

EVERY MONDAY · 7 MINUTES

Bring GMP updates into your week.

The Pragmatic GMP turns one topic, one real-world example and inspection trends into practical guidance.
Discover The Pragmatic GMP →

GxP Insights

Clean colour GuideGxP 2D editorial comic illustrating the GMP topic: TGA consultation on GMP inspection outcome transparency: what manufacturers should prepare for.

TGA consultation on GMP inspection outcome tran...

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...

TGA consultation on GMP inspection outcome tran...

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...

Illustrazione editoriale GuideGxP 2D a colori sul tema GMP: EU-PIC/S GMP Annex 15 revision: what the corrigendum means for validation and API manufacturers.

EU-PIC/S GMP Annex 15 revision: what the corrig...

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...

EU-PIC/S GMP Annex 15 revision: what the corrig...

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...

Clean colour GuideGxP 2D editorial comic illustrating the GMP topic: EMA Annex 22: What a GMP validation strategy for probabilistic AI may need.

EMA Annex 22: What a GMP validation strategy fo...

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 Annex 22: What a GMP validation strategy fo...

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...

Clean colour GuideGxP 2D editorial comic illustrating the GMP topic: EU veterinary GMP rules are now directly applicable: what QA, QPs and API supply chains need to do.

EU veterinary GMP rules are now directly applic...

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 for human...

EU veterinary GMP rules are now directly applic...

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 for human...

Clean colour GuideGxP 2D editorial comic illustrating the GMP topic: Revised PIC/S Recommendations on Qualification and Validation (PI 006-4) published.

Revised PIC/S Recommendations on Qualification ...

PIC/S has published PI 006-4, a revised 49-page guidance document on qualification and validation which supersedes PI 006-3 and enters into force on 1 October 2026. GMP manufacturers should now...

Revised PIC/S Recommendations on Qualification ...

PIC/S has published PI 006-4, a revised 49-page guidance document on qualification and validation which supersedes PI 006-3 and enters into force on 1 October 2026. GMP manufacturers should now...

Clean colour GuideGxP 2D editorial comic illustrating the GMP topic: PIC/S draft guidelines for new GMP Annex 22 on Artificial Intelligence.

PIC/S draft guidelines for new GMP Annex 22 on ...

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 applications, with...

PIC/S draft guidelines for new GMP Annex 22 on ...

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 applications, with...