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.
What is the difference between qualification and validation in GMP? Qualification proves that equipment and systems are fit for their intended use; validation proves that a process delivers...
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The cleaning validation master plan is the document that governs cleaning validation in multiproduct GMP sites. Here is how to structure it under Annex 15 and PIC/S PI...
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GMP regulations (Good Manufacturing Practice) ensure that medicines are consistently produced and controlled to the required quality standards. Here is what GMP regulations are, which documents define them...
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A pharmaceutical quality agreement template defines responsibilities and controls when a GMP activity is outsourced. Practical guide based on EU GMP Chapter 7, the 2016 FDA guidance and...
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IQ OQ PQ meaning: Installation, Operational and Performance Qualification under EU GMP Annex 15. The three qualification stages explained with requirements, documents and typical audit pitfalls.
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The Product Quality Review (PQR) is the annual quality review required by Chapter 1 of the EU GMP. Here are the 12 minimum contents, the comparison with the...
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The European Commission has published a revised Annex 19, “Reference and Retention Samples”, in EudraLex Volume 4. Applicable from 24 September 2026, the revision adds specific guidance for...
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Learn how to make the Validation Master Plan truly risk-based and lifecycle-oriented: risk policy, change control, KPIs, master list and audit-proof strategies.
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How cleaning validation acceptance criteria calculation works in practice: from HBEL and PDE to MACO, down to the swab limit corrected for recovery. Formulas, a worked example and the findings...
How cleaning validation acceptance criteria calculation works in practice: from HBEL and PDE to MACO, down to the swab limit corrected for recovery. Formulas, a worked example and the findings...
How to write a GMP quality manual that truly describes your pharmaceutical quality system: contents required by ICH Q10, a proven structure, differences from the Site Master File, practical steps...
How to write a GMP quality manual that truly describes your pharmaceutical quality system: contents required by ICH Q10, a proven structure, differences from the Site Master File, practical steps...
How to write a GMP deviation report that stands up in audit: a template with the 10 key sections, a worked example and the mistakes inspectors cite most often. With...
How to write a GMP deviation report that stands up in audit: a template with the 10 key sections, a worked example and the mistakes inspectors cite most often. With...
What is the difference between GMP and GLP? GMP governs the manufacturing and quality control of medicinal products, while GLP governs nonclinical safety studies. A practical guide with EU/FDA regulatory...
What is the difference between GMP and GLP? GMP governs the manufacturing and quality control of medicinal products, while GLP governs nonclinical safety studies. A practical guide with EU/FDA regulatory...
What is the difference between qualification and validation in GMP? Qualification proves that equipment and systems are fit for their intended use; validation proves that a process delivers reproducible, compliant...
What is the difference between qualification and validation in GMP? Qualification proves that equipment and systems are fit for their intended use; validation proves that a process delivers reproducible, compliant...
The cleaning validation master plan is the document that governs cleaning validation in multiproduct GMP sites. Here is how to structure it under Annex 15 and PIC/S PI 006-4: essential...
The cleaning validation master plan is the document that governs cleaning validation in multiproduct GMP sites. Here is how to structure it under Annex 15 and PIC/S PI 006-4: essential...
PRACTICAL GMP TOOLS FOR PHARMA
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