EU GMP Annex 15: Practical Qualification and Validation Guide
Practical EU GMP Annex 15 guide covering VMP, DQ, IQ/OQ/PQ, process validation, CPV, cleaning validation and the validated state.
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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.
✓ 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.
Cleanroom Qualification (ISO 14644-3): Guide to Essential Tests
Operational guide to cleanroom qualification under ISO 14644-3:2019 and EU GMP Annex 1: HVAC tests, acceptance criteria, airflow studies, recovery and requalification.
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Annex 1 GMP 2023: Guidance on Contamination Control Strategy
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.
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ISO 14644 and GMP Annex 1: What is the real relationship?
Confusing ISO 14644 with GMP Annex 1? We explain the relationship, the differences (Grades vs. Classes), and the critical management of particles ≥5 µm.
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Technological Innovations in Pharmacovigilance: From EudraVigilance to Artificial Intelligence
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...
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Pharmacovigilance: Updates on risk minimization measures from the GVP XVI review
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...
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Drug Traceability and Serialization: From the European DMF to the US DSCSA
Pharmaceutical traceability is now a global priority. From the European Anti-Falser Directive (DMF) to the US Drug Supply Chain Security Act (DSCSA), companies must adapt their serialization and...
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EU pharmaceutical law reform: what's changing and what impact will it have on companies?
In 2023, the European Commission presented a proposal to reform pharmaceutical regulations, intended to transform access to medicines and the rules for companies in the sector. Discover the...
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Cleanroom Environmental Monitoring: Audit-Ready...
How to build an effective Environmental Monitoring Programme: particles, microbiology, ΔP, alert/action limits, trending, data integrity and response to deviations.
Cleanroom Environmental Monitoring: Audit-Ready...
How to build an effective Environmental Monitoring Programme: particles, microbiology, ΔP, alert/action limits, trending, data integrity and response to deviations.
Cleaning and Sanitisation in Cleanrooms: ISO 14...
How to build a robust cleaning & sanitisation programme: surfaces, frequencies, disinfectants, residues, special cleaning and audit readiness.
Cleaning and Sanitisation in Cleanrooms: ISO 14...
How to build a robust cleaning & sanitisation programme: surfaces, frequencies, disinfectants, residues, special cleaning and audit readiness.
Impact Assessment in Cleanrooms: Practical Guid...
How to perform an effective cleanroom Impact Assessment: technical factors, real examples, mitigations and integration with OCP/CCS.
Impact Assessment in Cleanrooms: Practical Guid...
How to perform an effective cleanroom Impact Assessment: technical factors, real examples, mitigations and integration with OCP/CCS.
Operations Control Programme (OCP) for Cleanroo...
OCP ISO 14644-5:2025: structure, minimum content, QRM/CCS integration and audit readiness. Real-world examples and common inspection pitfalls.
Operations Control Programme (OCP) for Cleanroo...
OCP ISO 14644-5:2025: structure, minimum content, QRM/CCS integration and audit readiness. Real-world examples and common inspection pitfalls.
Cleaning Validation GMP: What Inspectors Look For
FDA and EMA Audits on Cleaning Validation: Requirements, Critical Documents, and Errors to Avoid
Cleaning Validation GMP: What Inspectors Look For
FDA and EMA Audits on Cleaning Validation: Requirements, Critical Documents, and Errors to Avoid
ISO 14644-5:2025: Practical Guide to Cleanroom ...
ISO 14644-5:2025 updates, OCP, risk-based approach, cleaning, monitoring, and change control. A practical approach for QA/GMP and cleanroom managers.
ISO 14644-5:2025: Practical Guide to Cleanroom ...
ISO 14644-5:2025 updates, OCP, risk-based approach, cleaning, monitoring, and change control. A practical approach for QA/GMP and cleanroom managers.
