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Tuesday, April 9, 2024

DESCRIPTION OF MEETING: “Infection Prevention through Sterility Assurance & Microbiological Quality: Reflections from a Patient & Industry SME”

Dawn Nestola, Director Sterility Assurance & Microbiological Quality, GlazoSmithKline.

Sterility assurance and microbiological quality (SA & MQ) are fundamental to the production of pharmaceuticals/biopharmaceuticals, advanced therapy medicinal products (ATMPs), medical devices, and over-the-counter (OTC) medicines, contributing to product quality, safety, and promoting infection prevention in patients and consumers.

Recent updates to EU Annex 1 have mandated that manufacturers develop and actively maintain a robust contamination control strategy (CCS), and end-to-end SA & MQ are core to this regulatory requirement. Although a CCS primarily focuses on activities directly controlled by a manufacturer, elements that extend beyond the bounds of a GMP facility's four walls are just as important. In fact, SA & MQ begin elsewhere, with suppliers and sub-suppliers who provide, for example, device components and subcomponents, packaging components, manufacturing consumables (often sterile single-use systems), sterilization services, and raw materials, including aseptically collected patient cells (via apheresis), which may be the primary raw material in an ATMP. Likewise, SA & MQ do not terminate when a released product leaves the manufacturing facility, bound for a distribution center or customer. In contrast, SA & MQ end with each successful patient or consumer outcome when a product of appropriate microbiological quality (for its intended use) is consumed and/or properly used by the medical practitioner or recipient.

The speaker's presentation will focus on her patient experience with a life-threatening medical condition and offer reflections, through the lens of an industry SME, on her treatment journey and how SA & MQ contributed to her positive patient outcome.

For more information visit the PDA Delaware Valley Chapter webpage.


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