GxP Insights
Annex 15: Practical Guide to GMP Validation and...
A step-by-step guide to Annex 15: from Validation Master Plan (VMP) to Continuous Process Verification (CPV). Learn how to implement the lifecycle.
Annex 15: Practical Guide to GMP Validation and...
A step-by-step guide to Annex 15: from Validation Master Plan (VMP) to Continuous Process Verification (CPV). Learn how to implement the lifecycle.
Cleanroom Qualification (ISO 14644-3): Guide to...
Practical guide to HVAC qualification testing (OQ/PQ) according to ISO 14644-3: HEPA filter integrity testing, smoke testing (flow visualization), recovery testing and more.
Cleanroom Qualification (ISO 14644-3): Guide to...
Practical guide to HVAC qualification testing (OQ/PQ) according to ISO 14644-3: HEPA filter integrity testing, smoke testing (flow visualization), recovery testing and more.
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...
Pharmacovigilance: Updates on risk minimization...
The third revision of Module XVI of Good Pharmacovigilance Practices (GVP) came into force in August 2024. Learn what's new, the impact on pharmaceutical companies, and how to adapt internal...
Pharmacovigilance: Updates on risk minimization...
The third revision of Module XVI of Good Pharmacovigilance Practices (GVP) came into force in August 2024. Learn what's new, the impact on pharmaceutical companies, and how to adapt internal...