Laboratory Services Directorate Quality Manual

The Pharmacy and Poisons Board is committed to a policy of providing exemplary service with respect to performing accurate testing and analysis of Health Products and technologies. This manual describes the quality management system being implemented at the Pharmacy and Poisons Board Quality Control laboratory (PPB QC). The PPB QC laboratory shall be concerned with the sampling and testing of HPTs, and with the documentation that ensures that the necessary and relevant tests are actually carried out and that HPTs registered in Kenya are of acceptable quality, and compliant with the Marketing Authorization requirements. The laboratory will not be confined to laboratory operations only but will be involved in many decisions regarding the quality of HTPs supplied to Kenya.

The purpose of this manual is to describe the quality management system employed at the PPB QC laboratory which includes documented procedures established by the laboratory as well as the overarching PPB Quality management system that meets the ISO/IEC 9001:2015 and ISO 17025:2017 requirements.