Developing an Evidence-Informed Strategic Framework for Veterinary Vaccine Manufacturing Modernization Toward PIC/S GMP Compliance

Information from the abstract

Background/Objectives: Veterinary vaccine manufacturing is essential for controlling transboundary animal diseases, strengthening animal health systems, and supporting livestock development, particularly in Southeast Asia where livestock production continues to expand. However, modernization toward Pharmaceutical Inspection Co-operation Scheme (PIC/S) Good Manufacturing Practice (GMP) compliance remains challenging because it requires coordinated development across regulatory, technical, organizational, financial, and governance domains. This study aimed to develop an evidence-informed strategic framework for veterinary vaccine manufacturing modernization through a structured and systematically documented framework development methodology integrating multidisciplinary evidence and practice-informed implementation experience. Methods: An evidence-informed framework development study was conducted through the multidisciplinary integration of multiple evidence sources, including international regulatory guidance, peer-reviewed scientific literature, multidisciplinary feasibility assessment, and practice-informed implementation experience derived from a government-commissioned consultancy project. Framework development followed a structured methodology comprising evidence collection, evidence categorization, multidisciplinary evidence synthesis, framework development, iterative refinement, and expert-informed validation. Only generalized methodological principles and potentially transferable implementation knowledge were incorporated to ensure confidentiality of project-specific information. Results: Multidisciplinary evidence synthesis identified ten evidence domains encompassing regulatory, technical, organizational, economic, legal, environmental, governance, workforce, infrastructure, and implementation considerations. These domains were translated through a structured process into an evidence-informed strategic framework organized around four sequential modernization phases—Design, Construction, Validation, and Continuous Improvement—supported by cross-cutting strategic enablers. Iterative refinement through expert review, technical consultation, and implementation verification strengthened the framework’s scientific consistency, regulatory alignment, and practical applicability. Conclusions: Veterinary vaccine manufacturing modernization should be regarded as a multidisciplinary organizational transformation rather than solely as an infrastructure or engineering project. Beyond proposing a strategic framework, this study provides a transparent, systematically documented and traceable methodology for translating multidisciplinary evidence into strategic decision-support tools. The proposed framework may assist governments, regulatory authorities, vaccine manufacturers, and researchers in developing evidence-informed modernization strategies for veterinary biological manufacturing systems, particularly in low- and middle-income countries, subject to adaptation to specific regulatory, technical, institutional, and resource contexts.

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Related topics: Animal Disease Management and Epidemiology · Diphtheria, Corynebacterium, and Tetanus · Vaccine Coverage and Hesitancy