Auditoria de operadores logísticos

To audit your logistic operator is one of the most crucial aspects of Good Distribution Practices (GDP) to ensure the quality of the medicinal product.

Chapter 7 of the GDP guidelines about outsourced activities, emphasized on the importance of monitoring and control every outsourced activity:

¨Any activity covered by the GDP guide that is outsourced should be correctly defined, agreed and controlled in order to avoid misunderstandings which could affect the integrity of the product. There must be a written contract between the contract giver and the contract acceptor which clearly establishes the duties of each party¨.


It is highly important to control the quality of the outsourced activities carried out by the logistic distributors.

To audit the distributors quality system, it is required to study and work on several aspects such as the documentary system verification, staff involved, staff training, processes, facilities, maintenances and cleaning processes, pest control, environmental conditions, etc.

To audit the distributors quality system, it is required to study and work on several aspects such as the documentary system verification, staff involved, staff training, processes, facilities, maintenances and cleaning processes, pest control, environmental conditions, etc.

Some phases included while carrying out a logistic operator Audit are:

  • Planning (including collecting documents from previous audits and gathers preliminary statements from involved parties, planning the scope, etc.)

  • Preliminary Review (evaluating the way that a company operates and takes into account the organization’s internal processes, etc.)

  • Fieldwork (visiting the facilities, interviewing the employees, determinate points of improvement, etc.)

  • Audit report (includes recommendations and CAPA)

Also, this audits process can be extended to other parties involved on the distribution chain.

Qualipharma provides comprehensive support on outsources activities suppliers ‘audits.