Raw materials: Patient-centric requirements for the supply of raw materials
Raw material variability and control of the supply chain are important issues for the biopharmaceutical industry. The industry is still at an early stage in the journey to align the supply base with biopharma's requirements to improve patient well-being by assuring product safety and meeting ever-increasing regulatory demands. This requires increased understanding, monitoring and control of raw materials. Patient well-being is best assured by reducing or eliminating variability of the finished drug product, and this can be achieved, in part by targeted reduction and/or elimination of variation in raw materials. Our challenge is to align the supply system to the patients' needs. This paper highlights 10 areas of practice endorsed by leading global biopharmaceutical manufacturers to start to address and reduce raw material variation through our supply chains. These are:
- Patient-centered organizational culture
- Control and elimination of sources of variation
- Good Manufacturing Practice (cGMP)
- Fit-for-purpose specifications
- Change notification and early warning
- Risk management
- Traceability, transparency, and trust
- Technical due diligence and audits
- Root cause investigations
- Data management
Patients have the right to expect safe and effective medicines as intended by the biopharmaceutical industry. This is the guiding principle of the Raw Material Variability workstream who recognize that the quality of raw materials can have a direct impact on the safety and efficacy of those medicines. An organizational culture that is patient-centric ensures that all parties along the supply chain make the patient's needs the center of all decisions.
The control and elimination of sources of variation in raw materials is essential to ensure patient safety and medicine efficacy as well as product quality and process performance. Collaboration across the supply chain is needed to achieve supply chain reliability and ensure that the correct processes and tools are in place to monitor and control variation. GMP code of practices assures that the proper design, monitoring, and control of processes and facilities are in place. Applying a good manufacturing practice mindset across the supply chain can help assure that raw materials are compliant with requirements for their intended use.
Suppliers and biopharmaceutical manufacturers need to work closely together to align a given raw material's specifications with the material's intended use. These specifications should be 'smart' in as much as they set appropriate tolerances for the material based on the process sensitivity to those raw material attributes. 'Fit for purpose' specifications is the aim but these need not be necessarily custom as maximizing the use of standard specifications can reduce cost, lead times and help address risks and quality concerns.
The supply chain of raw materials to manufacturers is inevitably affected by changes to the supply or the product; manufacturers need to be given sufficient warning and appropriate detail of the reasons for the change via an agreed and robust change notification and early warning process so that they can evaluate and plan for the impact of the change. Sometimes the suppliers do not know what impact a change will have on the manufacturing process which can result in either an increased burden on the manufacturer, or in the case of under notification, a detrimental effect on the manufacturing process and potentially the patient.
With the safety and efficacy of the drugs supplied to patients as a key tenet of the guidelines, risk management becomes essential requiring both suppliers and manufacturers to each asses their own supply chains to ensure understanding and ranking of the inherent risks.
An integrative and collaborative approach between suppliers and manufacturers is needed to make sure the understanding and mitigation of risks is aligned. The guidelines recommend a collaborative approach to mapping the supply chain to determine risks therefore increasing transparency, visibility and trust. This enables manufacturers to share the intended use of the raw materials with suppliers and harmonize material sources and specifications.
Establishing key supply partnerships is viewed as ideal as this can create value for both parties but it does require extensive sharing of information, integration of processes, and co-ordinated decision-making which is a significant move away from the traditional supplier-manufacturer relationship.
Currently manufacturers perform technical due diligence and audits on their suppliers as part of risk management. This includes a mutual review examining the essential material attributes of the raw material for its intended application; assessment of the supplier manufacturing processes; audits of supplier facilities and processes to ensure the robustness of the supply chains; audits of supplier controls including effective strategies for controlling the quality of the raw materials which includes the process and analysis, packaging, storage and shipping.
This audit process also looks at the processes surrounding change management and notification to manufacturers. In the event of a problem with the raw material, a root cause investigation must be carried out with an action plan to minimize the effect of the issue and prevent it from happening in the future. The type of root cause investigation conducted will depend on the severity of the issue especially if it entails a recall and both suppliers and manufacturers should apply the principles of 'Corrective and Preventative Action' (CAPA). The guide suggests that the success of this process depends heavily on the strength of the relationship between the manufacturer and the supplier and their shared accountability.
Manufacturing process and product related data plays a crucial role in enabling product improvements and process optimizations. Data management involving the sharing of scientific and technical expertise by suppliers with companies and regulators not only becomes part of the due diligence process but improves product understanding, identifies sources of variation and reduces raw material variability. Confidentiality agreements allow the exchange of data between suppliers and companies whilst adhering to data formats standards where they exist.
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