At Validation Solutions, we deliver end-to-end process and cleaning validation aligned with EU Annex 15, FDA Process Validation Guidance, and modern lifecycle principles. Our approach focuses on understanding your process, defining critical parameters, and establishing a robust control strategy that ensures consistent, repeatable product quality. We support the full lifecycle from process design through qualification and continued process verification, including PPQ protocol development, execution, and data evaluation.
For cleaning validation, we develop scientifically justified strategies, including MACO calculations, residue chemistry, swab/rinse methods, and worst-case product selection. Every validation programme is customised to your products, equipment, and regulatory environment.