With the rapid growth of single-use systems (SUS) for drug production, especially by drug manufacturers with multiple locations across the globe, there are many risks associated with underestimating the regulatory compliance, manufacturing, and quality requirements of these systems. For example, using SUS introduces new logistical challenges that if not properly understood and planned for can leave biopharma manufacturers vulnerable to supply chain complexities.
To minimize these risks, biopharma manufacturers can benefit by adopting a global single-use supply chain strategy early in the drug development lifecycle and carefully evaluating their chosen single-use equipment and materials suppliers. When reviewing a prospective supplier, there are two primary considerations for biopharma manufacturers to keep in mind: The supplier’s regulatory and quality compliance, and its commitment to supply chain operational excellence.
Regulatory and quality compliance
There are four main categories to review when evaluating a single-use provider’s regulatory and quality compliance initiatives.
First, the environment where the single-use equipment and materials are being manufactured should be checked to ensure proper controls are in place to monitor and track environmental conditions where the materials are produced. The production facility should have documented evidence of annual cleanroom recertification and a validated process showing a rotational cleaning regimen, as well as air/surface viable and non-viable particulate testing being carried out on a scheduled basis. Cleanrooms should also be monitored for real-time temperature, humidity and differential pressure monitoring.
Second, product sterility validation that follows a well-defined and recognized reference standard identified by regulations such as ANSI/AAMI/ ISO 11137 should be investigated. There should be documented evidence this validation is performed on a routine basis. The single-use supplier’s ability to perform lot release testing on finished products to verify that the product meets certain requirements after sterilization is the third item that should be reviewed. Most requests for this testing include USP <85> for bacterial endotoxins and USP <788> for particulate contamination.
The fourth and potentially most important item for reducing risk in the single-use supply chain is to fully understand a supplier’s quality risk management (QRM) program. A key element of ISO 9001 and cGMP related to quality is risk-based decision-making, and a qualified single-use supplier will have developed quality metrics to control the risks associated with their product manufacturing.
Essential steps in risk management generally include risk assessment (identification, analysis, and evaluation); risk control (mitigation, reduction, and acceptance); and risk review.