Kenya’s national drug regulatory authority has issued an advisory to all manufacturers, distributors, wholesalers, retailers, and healthcare facilities emphasizing the importance of adhering to Good Distribution Practices (GDP) to prevent product degradation and maintain product integrity throughout the supply chain.
All manufacturers, distributors, wholesalers, retailers, and healthcare facilities are required to handle health products and technologies (HPTs) in accordance with specified temperature and humidity conditions. Strict compliance with GDP is necessary to ensure the safety and efficacy of these products. Manufacturers must ensure that any HPT formulation intended for distribution is designed, developed, and tested to withstand high temperatures and humidity.
The regulatory authority, established under relevant legislation, oversees health products and technologies as well as the pharmacy profession. A key responsibility is to ensure patient safety through post-market surveillance.
Recent market complaints have highlighted cases of HPT degradation, often linked to improper handling and storage. These issues pose a significant threat to product quality, safety, and efficacy, ultimately impacting public health.
To address these concerns, market authorization holders must conduct stability studies in accordance with climatic conditions specific to the region to ensure formulations maintain their quality, safety, and efficacy throughout their shelf life. Additionally, robust packaging solutions must be implemented to protect products from moisture, heat, and environmental stress.
Manufacturers are required to clearly label storage conditions and special handling instructions on all product packaging to ensure effective communication with distributors and healthcare providers. Furthermore, market authorization holders must provide adequate training and guidance to all supply chain stakeholders on best practices for handling temperature-sensitive products.
Regulatory authorities will conduct inspections and compliance audits to enforce these requirements. Non-compliance may result in regulatory actions such as product recalls, license suspension, or other enforcement measures to ensure adherence to these critical guidelines.
