Regulatory Inspections

Involved with inspection of establishments across the medical product supply chain including manufacturers, distributors, re-packagers, re-labelers, importers, agents, traders, wholesalers, and retailers of medical products. Regulatory inspection is performed to ensure that operations at these establishments are carried out by approved standards, norms, and guidelines and are in compliance with the national medical products legislation and regulations.

Regulatory inspections entail different Good Practices (GXPs) including Good Manufacturing Practices (GMPs), Good Distribution Practices, and Good Clinical Practices. The Board is legally mandated to inspect and enforce GXPs throughout the supply chain, to make decisions concerning the issuance, suspension, or withdrawal of establishment licenses, and to issue authorizations or certifications for the activities performed by these establishments.

Several types of risk-based inspections are performed including pre-licensing or post-licensing, pre-approval or post-approval, announced or unannounced, and domestic or overseas inspections following uniform procedures incorporating quality system principles.

Guidelines and Procedures