Reflections on the Saudi FDA Regulatory Experience With Smart GxP Inspections

OBJECTIVES: This research aimed to evaluate the Saudi Food and Drug Authority's (SFDA) experience with smart GxP (Good Practice) inspections from 2020 to 2022. The study focused on assessing the accuracy of document evaluations and the effectiveness of meeting inspection objectives when using remote inspection methods compared to traditional on-site inspections.

METHODS: Data were collected from smart inspections conducted by SFDA, covering medical device manufacturers, pharmaceutical sites, warehouses, accreditation offices, scientific offices, and food manufacturing facilities. The smart inspections used remote tools like livestreaming and video conferencing. The study employed both descriptive and inferential statistics to evaluate the accuracy of document reviews and the extent to which inspection objectives were met.

RESULTS: Smart inspections showed a high degree of document evaluation accuracy and successfully met inspection objectives. Specifically:

• Medical Device Manufacturers: 53 sites inspected, 88.7% document evaluation accuracy, 79.9% objectives met.
• Pharmaceutical Manufacturers: 158 sites, 77.8% document evaluation accuracy, 79.2% objectives met.
• Accreditation Offices: 81 sites, 87.6% document evaluation accuracy, 80% objectives met.
• Local Manufacturing Sites: 1,607 sites, 95% document evaluation accuracy, 93% objectives met.
• Local Establishments: 2,339 sites, 92.6% document evaluation accuracy, 89% objectives met.

Despite their effectiveness, the SFDA noted that smart inspections should not completely replace on-site inspections due to limitations like technology constraints and the inability to physically inspect facilities.

CONCLUSIONS: Smart GxP inspections are a valuable alternative for maintaining regulatory oversight, particularly during the COVID-19 pandemic. They offer cost savings and increased inspection frequency. However, challenges such as ensuring data security, accurate document submissions, and reliable communication must be addressed. Smart inspections complement but do not fully replace traditional on-site inspections. Continuous refinement and integration of advanced technologies are recommended to enhance the effectiveness of remote regulatory assessments.