Audit Tools and Checklists for Good Distribution Practices

Warehouses and Distribution Facilities must be monitored very carefully. In the past, most attention was placed on the manufacturing aspects of medicinal products and raw materials. Today, also the supply chain must be monitored in an ongoing process. International authorities keep on focussing on Good Distribution Practice requirements. For example, the European Medicine Agency (EMA) is currently revising the Guideline on GDP.

Rx-360 has published some useful information about the control of so called Logistics Service Providers (LSP) who provide client companies with warehousing, distribution and logistics services. It is the intention of the new white paper to outline the elements of an effective Security Plan. In addition, the paper discusses mechanisms by which a manufacturer client can identify (or ‘map’) and prioritize the reviews of their third-party LSPs. Finally, the aspects of the audit and the follow-up actions, as well as two companion documents are discussed briefly. These documents provide a Template of Requirements for Third Party Logistics Service Providers and an Audit tool for oversight of Third Party Logistic Service Providers.

The new process as well as the documents should be used as tools by manufacturer clients to develop their own systems, contracts, audits and assessments that meet their risk tolerance levels.

Source: Press Release published by Rx-360