Guidelines for Establishing Manufacturing Facilities for Health Products & Technologies In Kenya

With increased influx of applications for setting up manufacturing facilities in Kenya, and given the responsibility to regulate the manufacture and trade of Health Products and Technologies, the Pharmacy and Poisons Board has developed this guidance notes for the industry in Kenya.

The primary purpose of this guidance is to promote the establishment and operation of manufacturing facilities that adhere to the highest standards of quality, safety, and efficiency. By sharing best practices, regulatory requirements, and industry insights, we aim to facilitate the creation of manufacturing facilities that can reliably produce health products and technologies that meet the needs of patients, healthcare providers, and the broader healthcare ecosystem.

This guidance is intended to facilitate the setting up of manufacturing facilities in Kenya fit for manufacture of quality health products and technologies that meet international standards as well as protecting personnel working in these premises. This guidance is intended to guide on establishment of manufacturing facilities for health products and technologies as well as ease of doing business.

Over the years, HPTs manufacturing has evolved so much that it is important for Pharmacy and Poisons Board to establish a guidance document to ensure that the development and maintenance of new and existing HPTs manufacturing facilities are done according to current international standards.

Taking note that Health Products & Technologies manufacturing premises often require substantial resources to construct and maintain, standardization in the construction of HPTs manufacturing is important for improving the health of the public in Kenya and in the region. This guidance therefore, is meant to act as reference to ensure appropriate planning, development and upgrading of the HPTs manufacturing facilities in Kenya.

We hope that this guidance will serve as a valuable resource for all stakeholders committed to advancing healthcare through the establishment of manufacturing facilities. By working together to uphold the highest standards and embrace innovation, we can collectively contribute to better health outcomes for individuals and communities