In our second entry of the GDP series we identified the different types of agents involved in the distribution of medicinal products. We also described how each of them introduces different levels of risk to the supply chain. It is important to characterize these agents and to clearly define the business relationships and responsibilities, in terms of the ownership of the product at any given moment during its distribution. Identifying the most critical ones will allow adapting the efforts for their control.
Later, the third post concluded that, in many cases, the best way to obtain the necessary information to effectively control the supply chain is by performing face to face audits at the agents’ facilities, where they can describe their processes and the elements related to them. Auditing the key agents in the supply chain is the first step to establish reliable GDP compliance strategies.
It is important to bear in mind that GDP compliance must be guaranteed for shipments and movements of products and that it is possible to perform GDP-compliant operations with agents that are not complying with GDPs at an organizational level.
In this sense, information acquired during audits can help to adjust and create GDP conditions for the operations, including the necessary level of protection through containers acting at a passive – or even active – level in order to ensure that the products are kept in the required conditions along the way. In addition, the new technologies available can guarantee the key elements of traceability and verification of compliance with these conditions, independently from the agents’ quality systems.
The approach to these audits should be in line with the understanding of the processes carried out by supply chain agents, while identifying the uncertainties and risks. It is crucial to establish a collaborative atmosphere, so that the criteria and actions to be set are efficient and satisfactory for all parties. At AFA we have excellent professionals, with broad experience on such scenarios. This experience makes us aware of the current situation and observant of the evolution of the logistics and distribution sectors aiming to provide services to the pharmaceutical industry. We always keep up to date to provide the best audit services which, as we have seen, are key elements in designing GDP compliance environments.
The efficient evaluation of logistics suppliers, therefore, consists in:
• An initial audit, crucial to identify the capability and risks.
• Continuous monitoring of data and indicators.
• Periodic follow-up audits based on the risks identified and the results obtained.
It is worth noting that some logistics companies have identified a business opportunity in offering GDP compliant operations. By adapting their processes and tools to comply with GDP requirements they are now targeting the pharmaceutical industry. This is an advantage for pharmaceutical companies which will go through less effort in selecting their logistics suppliers. We invite you to read this interesting case study of a logistic operator which went through an improvement process to offer GDP services.
At AFA, we understand the supplier evaluation process as something that goes way beyond auditing. To carry out this process as a mere formality, without strategic vision, is little less than dooming oneself to having problems in the future. These problems can be regulatory, economic and brand prestige, to name a few. The sooner the potential gaps are detected, the lower the overall cost for all the parties involved.
Outsourcing the supplier audits to an expert team, capable of analysing all the aforementioned aspects, will free up resources for other strategic tasks whilst assuring that the integration between pharmaceutical requirements and suppliers’ operations can be total and seamless.