The government through the Pharmacy and Poisons Board (PPB) has issued an advisory on the storage, handling and formulation of Health Products and Technologies (HPTs).
In a statement dated Wednesday, March 12, 2025, the board highlighted critical concerns regarding the degradation of HPTs due to improper storage and handling, which poses risks to product quality, safety, efficacy, and patient health outcomes.
“The Board has received multiple market complaints regarding HPT degradation, often linked to improper storage and handling. These issues pose a significant risk to product quality, safety, and efficacy, ultimately affecting patient health outcomes,” the poison board statement reads.
In the advisory, the PPB encouraged all stakeholders in the health sector to store and handle HPTs according to manufacturer-specified temperature and humidity conditions.
“All manufacturers, distributors, wholesalers, retailers, and healthcare facilities must store and handle HPTs according to manufacturer-specified temperature and humidity conditions. Strict adherence to Good Distribution Practices (GDP) is essential to prevent product degradation and maintain product integrity across the supply chain,” the poison board directed.
“Manufacturers must ensure that any HPT formulation intended for distribution in Kenya is designed, developed, and tested to withstand high-temperature and high-humidity environmental conditions.
Urging stakeholders to act immediately to maintain the integrity of HPTs from manufacturing to distribution, the board stated that it will conduct inspections to ensure compliance adding that non-compliance may lead to actions like product recalls or license suspension.
“The Board will conduct inspections and compliance audits to enforce these requirements. Non-compliance may result in regulatory action, including product recalls, license suspension, or other enforcement measures. We urge all stakeholders to take immediate action to comply with these directives and ensure the integrity of HPTs from manufacturing to end-user distribution,” the board stated.
It further outlined several measures that must be followed to maintain the integrity of the health products.
“Marketing authorization holders are therefore required to comply with the following; conduct stability studies in accordance with ICH Zone IVb climatic conditions to ensure the formulation maintains quality, safety, and efficacy throughout its shelf life; Implement robust packaging to protect products from moisture, heat, and environmental stressors,” the board outlined.
“Clearly label storage conditions and special handling instructions on all product packaging to ensure effective communication with distributors and healthcare providers; Provide adequate training and guidance to all supply chain stakeholders on best practices for handling temperature-sensitive products.
You might also like
