Manufacturers, distributors, wholesalers, retailers, and healthcare facilities will be required to comply with new rules for the storage and handling of Healthcare Products and Technologies (HPTs).
In a statement on Wednesday, March 12, the Pharmacy and Poisons Board (PPB) CEO, Fred Siyoi, said there has been a rising number of market complaints regarding improper storage and handling of HPTs, a trend that has raised multiple health concerns.
"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," he stated.
The Board has directed manufacturers to ensure that any HPT in development and intended for distribution is thoroughly tested to withstand high temperatures and high humidity environmental conditions.
Marketing Authorisation holders have been urged to conduct stability studies on these products to ensure that their formulation maintains quality, safety, and efficacy during storage.
Additionally, the holders have been encouraged to ensure robust packaging to shield HPTs from moisture, heat, and environmental stressors.
Furthermore, the PPB has called for clear labelling of storage conditions and special handling instructions on all product packaging to establish effective communication between distributors and healthcare providers on how the products should be handled.
Siyoi has also emphasised the need for adequate training and guidance for suppliers on handling temperature-sensitive products.
Manufacturers, distributors, wholesalers, retailers, and healthcare facilities have been directed to store these products strictly according to the manufacturer-specified temperature and humidity conditions.
PPB has asserted that adhering to these rules will be pivotal in upholding Good Distribution Practices (GDP) to guarantee product integrity in the supply chain.
"All manufacturers, distributors, wholesalers, retailers, and healthcare facilities must store and handle HPTs according to manufacturer-specified temperature and humidity conditions," he said.
"Strict adherence to Good Distribution Practices (GDP) is essential to prevent product degradation and maintain product integrity across the supply chain," he added.
The PPB has warned that non-compliance with the rules will lead to severe consequences, including product recalls, licence suspension, and other enforcement measures.
"The Board will conduct inspections and compliance audits to enforce these requirements. Non-compliance may result in regulatory action, including product recalls, licence suspension, or other enforcement measures," he said.
