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A Virtual Look at Risk Management for Prefilled Syringes

On April 15, the PDA Metro Chapter offered a webinar in lieu of an in-person dinner meeting due to the COVID-19 crisis. For this webinar, Jon Cammack, PhD, provided a look at “Risk Management for Combination Products.”

He pointed out that the U.S. FDA’s 2013 combination product rule (21 CFR Part 4) is far reaching and encompasses both legacy and new drug products. Within this rule, combination products consisting of a device and a drug must integrate the risk management—ICH Q9: Quality Risk Management for the drug portion and ISO 14971 Medical devices — Application of risk management to the device portion.

Risk management is a key element of design controls, explained Cammack.

The majority of his talk concerned a specific drug/device combination product—prefilled syringes. Here, the risk management process involves four phases: identifying hazards, evaluating associated risks, mitigating/controlling the identified risks and monitoring effectiveness of the controls.

The risk management process must meet FDA’s expectations under ICH Q9 and ISO 14971. Other risk management approaches are acceptable only if a strong rationale supports their application.

A number of other points were made during the Q&A. Regarding the design history file, Cammack recommends documenting early on and ensuring the file is readily available—an action that can help during an inspection. Another question concerned the filling process where the drug and device meet and if that particular step falls under ICH Q9 or IS0 14971. Due to the mechanical nature of this process and the fact that the actual chemistry of the drug can have an impact, he feels that in most cases, ISO 14971 covers this process.

The chapter thanks sponsors Bristol-Myers Squibb, Bracco Diagnostics and Lachman Consultants in addition to vendor sponsors ClorDiSys, Veltek, BDI, Ecolab, Wilco, Focus Laboratories and Commissioning Agents Incorporated for their support for the webinar.

For more information about upcoming chapter events, virtual and otherwise, please visit the PDA Metro Chapter website.

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