A Comparative Evaluation of Process Validation Requirements for Multivitamin Tablet Formulations in Nutraceutical and Drug Categories

Process validation plays a critical role in ensuring the quality, safety, and consistency of multivitamin tablet formulations across both pharmaceutical and nutraceutical sectors. Despite serving similar end-user needs, these two categories are governed by distinct regulatory frameworks, resulting in divergent validation requirements. This review presents a comparative evaluation of process validation approaches applicable to multivitamin tablets classified as either drugs or nutraceuticals. Key focus areas include differences in regulatory expectations, validation lifecycle stages, identification and control of critical process parameters (CPPs), documentation practices, and the application of quality risk management tools. The review also highlights emerging trends such as digitalization, real-time monitoring, and the adoption of Quality by Design (QbD) principles, particularly in high-risk nutraceuticals. By analyzing these aspects side by side, the article aims to assist quality assurance professionals, regulatory experts, and manufacturers in aligning validation strategies for improved compliance, product uniformity, and consumer safety. The insights provided may also support regulatory harmonization and the development of integrated quality systems across both product categories.