Guidance Document on Regulatory Measures on GMP, GCP and GDP Certification During Emergencies

The Pharmacy and Poisons Board has taken appropriate measures to minimize risks of shortages while ensuring continued availability of high standards of quality, safety and efficacy of medicines to patients amidst emergencies restrictions impacting on some on-site Good Manufacturing Practices (GMP), Good Clinical Practices (GCP) and Good Distribution Practices (GDP) inspections.

Due to travel restrictions attributed in part to emergencies like pandemics, domestic and international safety measures and related travel embargo it can become difficult to conduct on-site inspections related to GMP, GCP and GDP. However, mitigation measures can be taken to ensure that there is continued availability of safe, quality and efficacious medicines to Kenyans.

To achieve this, PPB will carry out continued re-certification of manufacturing sites and Contract Research Organizations using internationally accepted off- site inspection criteria through risk based and balanced approaches and extension of cGMP and GCP certification validity to accommodate for adjustment of inspection procedures, verification of standards while making sure that good practice standards are being adhered to.