Regulatory Inspections
Regulatory inspection function entails inspections of establishments across the health product and technologies (HPTs) supply chain including manufacturers, distributors, re-packagers, re-labelers, importers, agents, traders, wholesalers and retailers of medical products.
The purpose of regulatory inspections is to ensure that operations at these establishments are carried out in accordance with approved standards, norms, and guidelines and are in compliance with Pharmacy and Poisons Act (CAP 244 of the Laws of Kenya) and applicable national Good Practices (GXPs) guidelines. These national Good Practices (GXPs) guidelines are consistent with World Health Organization (WHO) recommendations and other internationally recognized guidelines.
The scope of the function applies to different Good Practices (GXPs) including Good Manufacturing Practices (GMPs), Good Distribution Practices (GDP) and Good Clinical Practices (GCP).
Good Manufacturing Practices Division
Introduction
GMP Division exists to ensure that personnel, premises and practices employed in the manufacturing of Health Products and Technologies comply with the defined codes of practice and other prescribed requirements through inspection of manufacturing facilities (both local and international)
As per CAP 244 of the Laws of Kenya, every person who is granted a manufacturing license is mandated to comply with good manufacturing practices. Additionally, marketing authorisation is granted upon confirming that the site of manufacture complies with Good Manufacturing Practices.
Good Distribution Practices Division
Introduction
GDP Division exists to ensure that personnel, premises and practices employed in the distribution of Health Products and Technologies comply with the defined codes of practice and other prescribed requirements through inspection of facilities of Wholesale, Retail, Hospital pharmacies and Ports of entries.
As per CAP 244 of the Laws of Kenya, every person who is granted a license to distribute and sell HPTs is mandated to comply with Good Distribution Practices.
Divisions
Regulatory Decisions