Regulatory Focus: Enhancing Container Performance in Sterile Manufacturing

Considering that container performance is the primary trait protecting product safety until the point of use, it will continue to receive increasing regulatory attention in the sterile manufacturing space. The updates to Annex 1 align with the regulatory shifts experienced across the globe by other regulatory bodies. Container performance must be validated and controlled, like all other high-risk quality attributes within the manufacturing environment. ICH Q8 and Q9 further articulate expectations associated with risk management, and USP 1207 dictates that deterministic CCI solutions should be deployed to assure CCI. At a fundamental level, the regulation, landscape, and technologies associated with container quality and performance are shifting to have better control and scientific understanding of parenteral quality.

Evolving Regulatory Landscape and Technological Shifts in Container Performance Assurance within Sterile Manufacturing.”

The industry is shifting to a holistic approach of CCI, in which there is heavy reliance on QbD to assure container performance. It is clear that to achieve the quality requirements laid out by regulatory bodies, there will need to be a concerted effort to improve the technology, the scientific methodology, and the depth of risk assessment for container closure systems. The regulatory guidance documents have set the objectives, and now good science must carve the path forward.

Oliver Stauffer

CEO at Packaging Technologies & Inspection (PTI)

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