ICH Q3D Elemental Impurities: List of Elements and PDEs
The complete ICH Q3D elemental impurities list: the 24 elements in Classes 1, 2A, 2B and 3 with oral, parenteral and inhalation PDEs. How to run the risk...
Read the article →GXP ACADEMY · ICH GUIDELINES
ICH Guidelines: connect the requirements and apply them systematically.
Practical analysis of the ICH Q, E, M and S families: pharmaceutical development, quality and risk, impurities, stability, CTD/eCTD dossiers, clinical trials and lifecycle management. Built to clarify what each guideline requires, how it connects to others and what evidence is needed in practice.
✓ ICH Q · Quality
✓ ICH E · Efficacy
✓ ICH M · Multidisciplinary
ICH Q · E · M · S
Understand the guidelines. Apply them as a system.
Quality, risk, impurities, regulatory dossiers and clinical trials explained through connections, operational criteria and expected evidence.
ICH Q1 Revision (2026): What Changes in Stability Testing
The ICH Q1 revision consolidates the Q1A-Q1F and Q5C guidelines into a single stability testing guideline, with Step 4 adoption expected in November 2026. Here are the confirmed...
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Nitrosamine Risk Assessment: Template and EMA/FDA Steps
How to build the nitrosamine risk assessment required by EMA and FDA: the three steps of the call for review, the template structure, CPCA limits and the mistakes...
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ICH Q1 Stability Testing: Guidelines and Requirements
A practical guide to ICH Q1 stability testing: Q1A(R2) storage conditions, batches, significant change and the new unified ICH Q1 expected in 2026. What QA, QC and regulatory...
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How to Apply the ICH E Guidelines: Operational Guide for QA/QP
Apply the ICH E Guidelines correctly: monitoring, TMF, risk management, audit trails and pharmacovigilance. Operational guide for QA/QP.
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ICH M Guidelines: how to prepare a CTD/eCTD step by step
Operational procedure to prepare a CTD/eCTD compliant with the ICH M Guidelines. For RA, CMC and QA teams.
Read the article →ICH - Guidelines
ICH Q3D Elemental Impurities: List of Elements ...
The complete ICH Q3D elemental impurities list: the 24 elements in Classes 1, 2A, 2B and 3 with oral, parenteral and inhalation PDEs. How to run the risk assessment with...
ICH Q3D Elemental Impurities: List of Elements ...
The complete ICH Q3D elemental impurities list: the 24 elements in Classes 1, 2A, 2B and 3 with oral, parenteral and inhalation PDEs. How to run the risk assessment with...
ICH Q1 Revision (2026): What Changes in Stabili...
The ICH Q1 revision consolidates the Q1A-Q1F and Q5C guidelines into a single stability testing guideline, with Step 4 adoption expected in November 2026. Here are the confirmed dates, what...
ICH Q1 Revision (2026): What Changes in Stabili...
The ICH Q1 revision consolidates the Q1A-Q1F and Q5C guidelines into a single stability testing guideline, with Step 4 adoption expected in November 2026. Here are the confirmed dates, what...
Nitrosamine Risk Assessment: Template and EMA/F...
How to build the nitrosamine risk assessment required by EMA and FDA: the three steps of the call for review, the template structure, CPCA limits and the mistakes to avoid....
Nitrosamine Risk Assessment: Template and EMA/F...
How to build the nitrosamine risk assessment required by EMA and FDA: the three steps of the call for review, the template structure, CPCA limits and the mistakes to avoid....
ICH Q1 Stability Testing: Guidelines and Requir...
A practical guide to ICH Q1 stability testing: Q1A(R2) storage conditions, batches, significant change and the new unified ICH Q1 expected in 2026. What QA, QC and regulatory teams need...
ICH Q1 Stability Testing: Guidelines and Requir...
A practical guide to ICH Q1 stability testing: Q1A(R2) storage conditions, batches, significant change and the new unified ICH Q1 expected in 2026. What QA, QC and regulatory teams need...
How to Apply the ICH E Guidelines: Operational ...
Apply the ICH E Guidelines correctly: monitoring, TMF, risk management, audit trails and pharmacovigilance. Operational guide for QA/QP.
How to Apply the ICH E Guidelines: Operational ...
Apply the ICH E Guidelines correctly: monitoring, TMF, risk management, audit trails and pharmacovigilance. Operational guide for QA/QP.
ICH M Guidelines: how to prepare a CTD/eCTD ste...
Operational procedure to prepare a CTD/eCTD compliant with the ICH M Guidelines. For RA, CMC and QA teams.
ICH M Guidelines: how to prepare a CTD/eCTD ste...
Operational procedure to prepare a CTD/eCTD compliant with the ICH M Guidelines. For RA, CMC and QA teams.
