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1. The newly released PDA/ANSI standard introduces a lifecycle-based approach to contamination control. What industry gaps or challenges was this standard primarily designed to address? The typical FMEA-based risk assessments that most of us are familiar are designed to evaluate risks in isolation, whereas this standard strives to assess contamination risk under an integrated system of controls.
Abstract: Brent Lieffers explains how the new PDA/ANSI 03‑2025 standard reframes aseptic quality risk management. Moving beyond isolated FMEAs, it evaluates the totality of contamination controls as layered “Swiss cheese” defenses, emphasizes prevention and detection of control failures, and provides a lifecycle dashboard to prioritize improvements and support Annex 1 expectations. 1. The newly released PDA/ANSI standard introduces a lifecycle-based approach to contamination control.
By Crystal M. Booth, PSC Biotech The first step in developing a sterility assurance program is to list each step in the process, beginning at the point of use and ending in sterile storage. Each step should be evaluated for ways to prevent contamination in the manufacturing process or environments. This article shares the components of a holistic sterility assurance program for an aseptic manufactured product.
By Brent Lieffers, Singota Solutions The drumbeat of continuous improvement programs and initiatives is a rhythm heard throughout the business world, and pharmaceutical companies are no exception in their embrace of pursuing improvements. More efficient and less error-prone processes, better employee training, and safer, more reliable equipment generally lead to improved products or services.
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