Qualification & Validation

Qualified equipment and validated processes are the foundation of consistent product quality — and a frequent focus of inspection. PharmExpert delivers qualification and validation across the lifecycle: equipment IQ/OQ/PQ, process validation, cleaning validation and analytical method validation, aligned to EU GMP Annex 15, ICH Q8–Q12 and FDA expectations.

We apply the modern, three-stage lifecycle model to process validation — process design, process performance qualification, and continued process verification — rather than the outdated one-time exercise. Critical process parameters and quality attributes are defined explicitly, and validation effort is focused where it affects the product, not spread evenly for the sake of documentation.

Cleaning validation is built on health-based limits: we derive or apply HBEL/PDE values and base MACO acceptance criteria on them, with sound sampling science and worst-case grouping for multi-product facilities. This is now the regulatory expectation, and legacy rule-of-thumb criteria no longer suffice.

Across all of it we author the validation master plan and protocols, execute the studies, and build the continued-verification and revalidation triggers that keep processes in a demonstrable state of control over time. The result is validation that is defensible at inspection and genuinely assures quality, not a binder that gathers dust.