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.
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.
GxP Insights
Cleaning Validation GMP: Requirements, Risks, a...
What Is Cleaning Validation GMP, What FDA and EMA Require, Common Errors, and the Impact on Quality and QA Careers
Cleaning Validation GMP: Requirements, Risks, a...
What Is Cleaning Validation GMP, What FDA and EMA Require, Common Errors, and the Impact on Quality and QA Careers
EU GMP Annex 15: Practical Qualification and Va...
Practical EU GMP Annex 15 guide covering VMP, DQ, IQ/OQ/PQ, process validation, CPV, cleaning validation and the validated state.
EU GMP Annex 15: Practical Qualification and Va...
Practical EU GMP Annex 15 guide covering VMP, DQ, IQ/OQ/PQ, process validation, CPV, cleaning validation and the validated state.
ISO 14644-3 Cleanroom Qualification: Tests, Cri...
Operational guide to cleanroom qualification under ISO 14644-3:2019 and EU GMP Annex 1: HVAC tests, acceptance criteria, airflow studies, recovery and requalification.
ISO 14644-3 Cleanroom Qualification: Tests, Cri...
Operational guide to cleanroom qualification under ISO 14644-3:2019 and EU GMP Annex 1: HVAC tests, acceptance criteria, airflow studies, recovery and requalification.
Annex 1 GMP 2023: Guidance on Contamination Con...
The 2023 revision of GMP Annex 1 introduces the Contamination Control Strategy (CCS). Learn what changes, the impact on QRM, and how to prepare your PQS.
Annex 1 GMP 2023: Guidance on Contamination Con...
The 2023 revision of GMP Annex 1 introduces the Contamination Control Strategy (CCS). Learn what changes, the impact on QRM, and how to prepare your PQS.
ISO 14644 and GMP Annex 1: What is the real rel...
Confusing ISO 14644 with GMP Annex 1? We explain the relationship, the differences (Grades vs. Classes), and the critical management of particles ≥5 µm.
ISO 14644 and GMP Annex 1: What is the real rel...
Confusing ISO 14644 with GMP Annex 1? We explain the relationship, the differences (Grades vs. Classes), and the critical management of particles ≥5 µm.
Technological Innovations in Pharmacovigilance:...
European pharmacovigilance is undergoing a transformation thanks to new technologies: updates to EudraVigilance, the introduction of the Product Management Service (PMS), and the first EMA guidelines for the use of...
Technological Innovations in Pharmacovigilance:...
European pharmacovigilance is undergoing a transformation thanks to new technologies: updates to EudraVigilance, the introduction of the Product Management Service (PMS), and the first EMA guidelines for the use of...
