A Situation Analysis Study and Preparedness for PIC/S Reassessment of Thai Food and Drug Administration

Abstract

Background: The Thai Food and Drug Administration (Thai FDA) was admitted as the 49^th member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) on 1 August 2016. As a PIC/S Participating Authority, the Thai FDA is subject to periodic re-assessment to ensure that its Good Manufacturing Practice (GMP) inspection programme remains in strict compliance with PIC/S requirements and demonstrates robustness, consistency, sustainability, and equivalence to international standards. Accordingly, a comprehensive situational analysis and structured preparedness strategy are essential to effectively support the PIC/S re-assessment process.

Objectives: This study aimed to analyze the current situation in order to identify overall gaps across multiple dimensions in relation to the PIC/S re-assessment criteria and to determine the extent to which existing practices remain in full compliance with PIC/S standards.  In addition, the study sought to synthesize a comprehensive conceptual framework to guide the Thai FDA’s organizational preparedness for PIC/S re-assessment.

Methods: This research employed a qualitative documentary research design comprising two principal phases. First, the current situation was analyzed against the PIC/S re-assessment framework using three analytical tools: SWOT analysis, gap analysis, and the Plan–Do–Check–Act (PDCA) continuous improvement cycle.  Second, the findings were synthesized to develop an integrated and organization-wide conceptual framework encompassing all institutional levels to support systematic preparedness for PIC/S re-assessment.

Results: The study found that the PIC/S re-assessment framework comprises 11 main elements, 38 sub-elements, and 78 indicators. Notably, 8 sub-elements are identified as "Critical Indicators," which require 100% gap closure. The situational analysis indicates that the Thai FDA has evolved from "system establishment" to a level of "Regulatory Maturity," driven by risk management and a concrete Quality Management System (QMS). However, the gap analysis highlighted key areas for improvement: (1) legal authority disparities between the Drug Act and the Herbal Products Act; (2) human resource constraints regarding specialized expertise in Advanced Therapy Medicinal Products (ATMPs); and (3) the necessity of updating GMP standards to the current version (PE009-17) and enhancing the project-based conflict of interest recording system. For the operational framework, the research synthesized a four-tier model (i.e., Strategic Direction, Standard Comparison, Operational Excellence, and PIC/S Indicators) along with a strategic roadmap and practical recommendations covering from policy to practitioner levels.

Conclusions: PIC/S re-assessment serves as a quality assurance mechanism to verify that member regulatory authorities continue to maintain GMP inspection systems aligned with PIC/S requirements, thereby promoting harmonization and mutual confidence among member authorities. The re-assessment of the Thai FDA is not solely to confirm formal compliance with PIC/S criteria, but also to ensure that its GMP inspection system remains robust, consistent, sustainable, and internationally comparable. Furthermore, it reflects the Thai FDA has transitioned from compliance-driven inspection to a mature, risk-based, and quality-system-driven inspectorate aligned with PIC/S principles.