SECURING A ROBUST SUPPLY CHAIN
Single-use technologies have been around for almost two decades but have become more prominent over the past few years in
biopharmaceutical manufacturing facilities as business leaders see the advantages with speed to market and cost of goods for
drug products. Single-use technologies in the past included single, discrete components such as filters that were used once
and then discarded. The evolution from single components to more complex assemblies incorporating containers, filters, sensors,
and other appurtenances provides advantages that were not readily available to the industry until recently. As these technologies
evolve, more capabilities will become apparent and will lead to more streamlined manufacturing operations. To facilitate the
increase in use of single-use technologies, a robust supply chain of single-use items is necessary to maintain production
The use of QMS is recommended in the ICH Q10 guideline Pharmaceutical Quality System (3). A QMS paired with risk-assessment tools can be used to establish the best approach for the adoption of single-use technologies
within a biopharmaceutical facility. The use of QMS tools ensures that single-use components and systems are manufactured
to defined quality standards. The keys to the successful implementation of a secure supply chain for single-use disposable
technologies may be accomplished by establishing contracts, qualification metrics, agreeable audit criteria, and robust supplier
quality and change-control programs.
A crucial component in securing the supply chain is to establish a contract between single-use component suppliers and the
end users. The contract should be explicit, clearly identifying terms, costs, service level agreements, and quality metrics
that the end user expects the supplier to meet. The contract, for example, should define metrics arrived at by both parties
that may be used to audit the manufacturing and delivery of single-use components to the end user.
With established metrics, both parties should address audit scope and frequencies that are mutually amenable. The measures
or corrective actions that are acceptable to both parties should be anticipated for common failure modes to ensure that neither
party overreacts and over commits to resolutions that will have a detrimental effect on the relationship. Consideration should
also be given to define dispute arbitration and resolution pathways.
Single-use component and system manufacturers as well as suppliers are also well served to implement risk-based quality control
and QMS programs to facilitate internal and external audit support and responses. Manufacturers specifically can leverage
risk assessment to identify key critical process parameters (CPP) for control of single-use systems (SUS). It is imperative
to establish a good working relationship between the supply chain and the end users. In effect, the contract supplier becomes
an extension of the company's business model. Success or failure is dependent on this relationship.