Alternate Suppliers Selection for Single-Use Systems

1. Introduction

Suppliers play a key role in Biopharmaceutical company’s success, and choosing a good supplier is a critical business decision to ensure the quality, safety and continue supply of pharmaceutical products. With single-use systems (SUSs) become more popular in bioprocessing, pharmaceutical companies now may have to manage hundreds to thousands of single-use products and components. Since SUS are pro to changes and often have more complex supply chains, sourcing strategies can be some of the most important issues for SUS users. Currently single sourcing and sole sourcing are very common practice for many SUS users. Single sourcing is different from sole sourcing for supplier availability: single sourced materials may have other suppliers that can provide similar products and services, while sole-sourced materials only have one supplier, there are no other options. Single sourcing and sole sourcing may provide benefits for an organization, but also present great risks.  Considering the complexity and criticality of a single-use system, having one or more backup suppliers (e.g., alternate suppliers) identified in the user systems may become necessary in the drug manufacturer’s strategic sourcing decisions and risk management strategy.

Single/Sole Sourcing Benefits Single/Sole Sourcing Risks
Reduction in product variation and training Simplify the supply chain management Qualification and administrative cost Reduction Failure at the supplier Failure at the sub-supplier(s) Greater supplier power to increase costs

2. Alternate Supplier Selection Considerations

The alternate supplier selection process starts from the identification of the highest risks or criticality materials, understanding the material, function and performances needs, also all the available data that support material usage in the desired bioprocessing application (Fig. 1). Once the needs of alternate source(s) (in some cases even tertiary supplier for most critical items) are identified, available suppliers and their proposed alternative products to the current ones need to be further evaluated. In any case, a risk- and science based assessment should be used to determine the level of testing and validation required for the new materials and suppliers. Once the best available suppliers are identified based on the needs, sourcing strategy and user-supplier agreements will be put in place to finalize the sourcing strategy. This relationship and agreement will be continuously monitored, maintained and improved to maximizing mutual benefits.

Fig. 1. Examples of alternate supplier selection process flow.

Materials of Construction (MOC) Materials of construction is a principle factor when considering an alternate source of the single-use systems. It will provide time and cost saving benefit if the user can identify materials as close as possible (e.g., “like-to like”) to the materials that are already qualified. If the materials are incomparable from two suppliers, the secondary supplier’s materials must be subjected to the same comprehensive qualification process as that of the primary supplier. In some cases, the single-use product suppliers may already qualified alternate polymer raw material sources as their supply risk mitigation strategy, the resulting materials might be sufficient to be used as alternative materials for low risk applications. For high risk materials, the end users may have to perform gap analysis to determine if additional testing is required to demonstrate material comparability, including physical, mechanical testing under usage conditions, and extractables/leachables (E/L) concerns. It is important to note that the manufacturing processes and testing methods may impact polymer properties and performance, and testing results, it is always recommended for end-users to perform application specific evaluations to determine if two materials are comparable. 

Single-Use Components and Final Products  Single-use systems are combination of different components such as fitting, tubing, filters, connectors, bag chambers, etc. The choice of components and design of the system often determine their function and performance. Best design should minimize material usage, accessories, and enable operation simplicity. It is beneficial if similar product form, fit and function can be provided by the alternate supplier, and having a backup policy of sourcing the same component from at least two different suppliers can be adopted. In an ideal state, dual sourcing suppliers should have completely independent supply chains to minimize the potential for a single change impacting both components. Once design is finalized, the selected suppliers should be able to meet the supply demands, at the meantime, be able to provide supporting documentations and study data to demonstrate that the final products can meet user requirements. In the case that the single-use components are sourced from sub-suppliers, the risk mitigation strategies of sub-supplier’s components should also be evaluated. End-user may audit the supplier to ensure they met requirements in supplier quality system, technical capability, and cGMP standards.

Supplier Relationships  End-users should seek suppliers that can provid good supports, process expertise, and technical advice that may add value to the business. Selection of an alternate supplier that are already exists in the end-user’s system helps reduce the cost of supplier qualification process. The supplier should be able to produce consistent top-quality products without any significant compliance and quality system failures. Appropriate risk control system should in place at supplier side to protect the security and supply of the raw materials and finished assemblies, ensuring they can be delivered at committed timelines. Pricing place an important part, but should not be the only decision factors. Good customer services are also extremely important which include open communication, flexibility, customized solutions, and strong technical supports. The end-users need to evaluate the supplier’s performance and understand total cost of ownership, ultimately build strategic user-supplier partnership that creates values for both parties.

Dual Sourcing Management  There are multiple supply chain risk categories, including capacity, catastrophic risk, quality risk, financial risk, management risk, contractual risk, and market risks. While multiple sourcing may reduce dependency on single suppliers, it may increase other risks such as management or contractual risks. All risks should be evaluated holistically to guide the end-users to make the appropriate sourcing decisions. Once the backup supplier is identified, both supply chains have to be managed properly and need to be exercised regularly, the users also need to determine what product to use and when to use it.

3. Conclusion

As single-sourcing and sole-sourcing are common practices for most single-use systems used in bioprocessing, more and more end-users have realized the importance of identifying a backup source at least for most important and critical systems. Depend on the size of the company and complexity of the single-use systems, the alternate supplier selection process can be simplified or more involving. A cross-functional team efforts from procurement, production, planning, quality, and technical support functions may needed to make the final supplier selection decision. Materials of construction, component comparability, final product quality, and supplier relationship are all factors should be examined in the process. Once the alternate supplier is identified, materials from these sources should be properly managed and routinely exercised to realize the benefits of multiple sourcing.