Kenya Good Manufacturing Practices Guidelines

The Pharmacy and Poisons Board (PPB) has adopted and published this document that contains multiple technical guidelines on Good Manufacturing Practice (GMP) published by the World Health Organization (WHO). It references separate and specific guidance and procedure in cases where WHO makes recommendations for National Regulatory Authorities to develop country-specific guidance to suit the local circumstances or national requirements

Non-technical GMP guidelines developed to guide the local manufacturing Industry and PPB GMP inspectors have been developed and published by PPB. As much as practicable, these too are developed in line with internationally recognized guidelines. Through the implementation of the guidelines in this document in regulatory oversight of GMP inspections, PPB shall better oversight manufacturers of Health Products and Technologies (HPTs) manufactured in, imported into, or exported from Kenya. It will ensure that products are consistently produced and controlled according to the quality standards appropriate to their intended use and as require by the marketing authorization or product specification.

The Board shall reference the WHO guidelines in updating and implementing this guidance document in keeping with regulatory best practices.