P331: A Decade of GCP Inspection in Malaysia: An Analysis of Findings from Trial Sites, Sponsors/CROs & Phase 1 Units
Poster Presenter
Fadhilah Hasbullah
GCP Inspector
National Pharmaceutical Regulatory Agency (NPRA) Malaysia Malaysia
Objectives
This study aims to analyse trends and patterns for Good Clinical Practice (GCP) inspection findings in Malaysia from 2015 to 2024, identify common areas of deficiencies, and assess the statistical significance of finding distribution across trial sites, sponsors/CROs, and Phase 1 units.
Method
NPRA GCP inspection data (2015-2024) were extracted and graded, with deficiencies categorised according to EMA (Annex 1). The data were processed and analysed using open-source tools to explore key deficiency areas and distribution patterns across inspected facilities.
Results
A total of 81 Good Clinical Practice (GCP) inspections were conducted by the National Pharmaceutical Regulatory Agency (NPRA) between 2015 and 2024, covering 60 clinical trial sites, 17 sponsors/contract research organisations (CROs), and 4 Phase 1 Units, with most sites located in Malaysia (99.17%).
A total of 599 findings were documented, of which 517 (86.31%) were identified during routine inspections, and 82 (13.69%) during triggered inspections. Findings were graded as critical (46; 7.68%), major (160; 26.71%), and minor (393; 65.61%). Upon categorising the findings using the European Medicine Agency (EMA) (Annex 1), it was found that more than 70% of the findings fell into three (3) main categories: general (222, 37.06%), investigational site (109, 18.20%) and investigational medicinal product (IMP) (90, 15.03%).
The grading distribution varied across facility types. Minor findings were most prevalent in Phase 1 Units (34; 68%) and trial sites (318; 70.04%), while major findings were more frequent among sponsors/CROs (46; 48.42%). A statistically significant difference was observed in the grading distribution across the three facility types (P < 0.001).
Sub-categories analysis showed that critical findings most often related to protocol compliance (selection criteria) (14.71%) and the informed consent process (14.71%). Major findings were associated with approval, amendments, and regulatory notifications (12.82%), while minor findings were mainly associated with source documentation (13.04%) and facilities/equipment (11.14%).
Conclusion
This study provides an overview of the distribution, severity, and key areas of deficiencies identified during GCP inspections. It offers valuable insights into Malaysia’s GCP compliance landscape and prevalent deficiencies in clinical trials. These insights equip stakeholders with evidence-based recommendations and highlight potential avenues for improving clinical trial conduct. Additionally, the findings establish a benchmark for comparing GCP compliance trends internationally.
The notable divergence in grading distributions across different inspected facilities suggests distinct patterns in evaluation or performance outcomes, potentially reflecting variations in operational practices, compliance standards, or other intrinsic factors unique to each facility type.
However, a key limitation of this study is that the inspection data analysed were limited to a specific time period (2015-2024) and did not encompass all GCP inspections conducted by NPRA. The analysis primarily focuses on inspections related to the registration of new medicines and biologic products in Malaysia.
