Good Distribution Practices (GDP)
All personnel involved in distribution activities are trained & qualified in the WHO requirements of GDP.
We have an appropriate infrastructure or “quality system”, encompassing the organizational structure, procedures, processes and resources; and systematic actions necessary to ensure adequate confidence that a product (or service) and documentation will satisfy given requirements for quality.
Good storage practice (GSP) is applicable in all circumstances where pharmaceutical products are stored throughout the distribution process.
Our vehicles and equipment used to distribute, store, or handle pharmaceutical products are suitable for their use and appropriately protective of the products to prevent exposure to conditions that could affect their stability and packaging integrity, and prevent contamination of any kind.
Our pharmaceutical products are stored and distributed in containers which do not have an adverse effect on the quality of the products, and which offer adequate protection from external influences, including microbial contamination.
Our pharmaceutical products are sold or distributed to persons or entities that are entitled to acquire such products in terms of applicable national, regional and international legislation. Written proofs of such authority are obtained prior to the dispatch of products to such person or entities.
The manufacturer communicates us all relevant conditions for storage and transportation to the entity (-ies) responsible for the transportation of pharmaceutical products. Such an entity (-ies) ensures the adherence to these requirements throughout transportation and at any intermediate storage stages.
Written instructions and records are available which document all activities relating to the distribution of pharmaceutical products, including all applicable receipts and issues. The name of the applicable entity should appear on all relevant documents.
We have a written procedure in place for the handling of complaints. A distinction is made between complaints about a product or its packaging and those relating to distribution. In the case of a complaint about the quality of a product or its packaging the original manufacturer and/or marketing authorization holder is informed as soon as possible.
We have a system which includes a written procedure to recall promptly and effectively pharmaceutical products known or suspected to be defective, with a designated person responsible for recalls.
Our system of quality assurance includes self-inspections. These are conducted in order to monitor the implementation and compliance with the principles of GDP and to trigger necessary corrective and preventive measures. Self-inspections are conducted in an independent and detailed way by a designated, competent person.