Securing and Qualifying Single-Use Technologies - The authors suggest techniques for mitigating risk and securing the supply chain for single-use components used in biopharmaceutical manufacturing. -


Securing and Qualifying Single-Use Technologies
The authors suggest techniques for mitigating risk and securing the supply chain for single-use components used in biopharmaceutical manufacturing.

BioPharm International Supplements
Volume 26, Issue 4, pp. s18-s23


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 capabilities.

Quality systems

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.

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