CQV Considerations for Single-Use Systems in Biopharmaceutical Manufacturing: A Practical Framework.

Single-use systems (SUS) have become the dominant technology across the biotechnology and pharmaceutical industry, and viral vector manufacturing is no exception. The standard CQV framework, however, was designed and largely developed for stainless steel, fixed-equipment biopharmaceutical manufacturing. This creates real qualification gaps that the industry is currently solving inconsistently. This article proposes a structured, fit-for-purpose CQV approach built around three pillars specific to single-use Biopharmaceutical facilities: equipment qualification of single-use systems, supplier qualification as the foundation of SUS CQV, and a event-driven requalification strategy for single-use multi-product facilities. The framework is illustrated through a detailed qualification example for a single-use bioreactor and is positioned against the current regulatory landscape, including EU GMP Annex 1, 21 CFR 211.65, PDA Technical Report No 66 and FDA gene therapy CMC guidance.