As we have seen in previous posts of the series, it is clear that Good Distribution Practices are essential factors to control the safety of the medicinal products along the complete supply chain. The responsibility of GDP compliance lies in the Qualified Person (QP), who releases the product to the market, or in the responsible person for the medicinal products’ distribution.
A general view of the complete supply chain, from raw materials to hospitals or pharmacies, is represented in the following scheme:
In the first series of the blog, about the change of paradigm in GMP compliance, we remarked the importance of the risk management tools in the adjustment of the efforts to ensure safety, efficacy and quality of medicinal products. GDP activities should also be included in the risk analyses, allowing pharmaceutical responsible people to have a clear idea about the critical agents and operations and to establish the correspondent risk control actions in consequence. In summary, risk analysis + risk reduction measures = risk management.
According to ICH Q9, Quality Risk Management (QRM) can be defined as a “systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle”.
To prepare detailed and accurate risk analyses, it is necessary to have profound knowledge about the supply chain processes and operations. Many times, it is not easy for the responsible person, the QP or the distribution responsible, to have such information. Audits to the agents involved in the supply chain can provide very useful information, which will allow better risk analysis exercises.
Once risks are well identified, the next step is to establish mitigation measures. These measures can be taken by the agents or by the QP or distribution responsible. Many GDP agents have difficulties to provide complete GDP compliant systems, as they offer services to multiple sectors and pharma-related activities are not the main business sector for them. In this case, risk management is essential to determine the possibilities to reduce risk through special measures for each shipment or operation, making it possible to GDP-compliant shipping even with companies which are not fully GDP oriented.
Risk reduction measures applied to critical operations should be validated, taking into account all the degrees of freedom, meaning that all possible variables should be considered. In this sense, Technical or Quality Agreements (TQA) between the responsible and the distribution agents are essential to establish “GDP compliant frameworks”. Setting conditions compliant with GDP in TQAs will allow the establishment of a reference for the follow up of the service and for performing GDP audits.
Characterization of the supply chain agents is the starting point for GDP compliance. For each of these agents the following sequence should be followed:
• Collecting all the information about the distribution agent.
• Identification of the critical agents and those of whom we do not have enough information.
• Audits to critical agents.
• Complete risk analyses with the results of the audits.
• Assessment of the suitability of the agents to determine the conditions in which they are safe and reasonably compliant.
• Establishment of technical agreements with the distribution agents which clearly set the conditions for distribution.
• Periodical follow up audits based on the compliance of technical agreements.
AFA has an important accumulated experience on GDP compliance since 2011:
• 2011 – 2012 Leading the Supply Chain Framework work group (GDP companies, health authorities and pharma companies. The outcome was the guidance for the control of supply chain.
• Risk analyses and audits performed: 35 carriers and 35 distributors and around 400 API and excipients audits that include the GDP compliance assessment of the supply chain.
We are able to provide you with complete assistance services in your process of becoming GDP compliant.