QUALITY MANAGEMENT SYSTEMS IN VACCINE CONTROL LABORATORIES: A SCIENTIFIC FOUNDATION FOR LOT RELEASE DECISION-MAKING AND STRENGTHENING NATIONAL CAPACITY

Abstract

Quality Management Systems (QMS) are essential for ensuring the safety, efficacy, and consistency of vaccines across production batches. In the context of increasingly complex biological manufacturing and globalized supply chains, regulatory systems must rely on robust laboratory quality frameworks to support decision-making. This study analyzes the role of QMS in vaccine control laboratories through a structured review of WHO guidelines, ISO standards, and regulatory practices from the FDA and EDQM. The findings demonstrate that QMS enhances data integrity, ensures reproducibility of laboratory testing, and provides a scientific basis for vaccine lot release decisions. Furthermore, the study highlights that lot release systems function as a critical risk control mechanism that complements manufacturer quality assurance processes. In Vietnam, strengthening QMS requires coordinated investment in infrastructure, workforce development, and regulatory alignment with international standards.