Kenya’s national drug regulatory Authority-Pharmacy and Poisons Board-has issued an advisory to all manufacturers, distributors, wholesalers, retailers, and healthcare facilities to strictly adhere to Good Distribution Practices (GDP) to prevent product degradation, and maintaining product integrity across the supply chain.
According to Dr Fred Siyoi, Chief Executive Officer (CEO), Pharmacy and Poisons Board (PPB), all manufacturers, distributors, wholesalers’ retailers and healthcare facilities must handle health products and technologies (HPTS) according to specified temperature and humidity conditions.
“Strict adherence to Good Distribution Practices (GDP) is essential to prevent product degradation and maintaining product integrity across supply chain,” Dr Siyoi said adding that, “manufacturers must ensure that any HPT formulation intended for distribution in Kenya is designed, developed and tested to withstand high temperature and high humidity environment conditions.”
PPB established under Pharmacy and Poisons Act (CAP 244) regulates health products and technologies and the Pharmacy profession. A key mandate is to ensure patient safety through post market surveillances.
Dr Siyoi said that the board has received multiple market complaints regarding HPTs degradation, often linked with improper handling and storage.
“These issues pose a significant threat to product quality, safety and efficacy ultimately affecting patients’ health.”
PPB urged market authorization holders to ensure that they conduct stability studies in accordance with ICH zone IVb climatic conditions to ensure formulation maintains quality, safety and efficacy throughout its self-life.
They are also asked to implement robust packaging to protect products from moisture, heat, and environmental stress.
“The board also urge manufacturers to clearly label storage conditions and special handling instructions on all products packaging to ensure effective communication with distributors and healthcare providers.”
Marketing authorization holders are also required to provide adequate training and guidance to all supply chain stakeholders on best practices for handling temperature sensitive products.
“The board will conduct inspections and compliance audits to enforce these requirements,” Siyoi said adding that, “non compliance may result in regulatory action including product recalls, license suspension or other enforcement measure
