Search results for " ICH"

Article Best Practices in Qualification of Single-Use Systems
Although there is no specific regulation dedicated to SUS, FDA’s Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (7), which is based on ICH Q7 (8), is a guidance documen…

Article Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
…ines put forward “strong scientific principles” to support the use of non-EEA drugs sourced from ICH regions as reference products. There could be more consistency between products from different lic…

Article HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
If used correctly, these new analytical methods can reduce analysis and product development time. ABSTRACT Monoclonal antibodies represent a significant portion of sales in the biopharma…

Article Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
QTPP is defined in ICH Q8 (R2) as "a prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and ef…

Article Filtration methods to overcome new challenges in viral safety
41 and ICH Q5A, and outlines the detailed mechanisms governing effective virus filtration, demonstrating how both specific methods and advanced filter design can overcome these challenges. READ FUL…

Article Mechanistic vs Statistical Models
Mathematical models are recommended by the ICH Q8 guidelines on pharmaceutical development to generate enhanced process understanding and meet Quality-by-Design (QbD) guidelines. Read on the d…

Article Top Process Development Trends for 2021 and a Look into 2022
Another aspect of this is the manufacturing process and its robustness as it pertains to compliance with process validation requirements set forth by the FDA and ICH (International Council for Harmoni…

Article A Look into the Future of Biopharmaceutical Quality
A Look into the Future of Biopharmaceutical Quality Quality experts share insights on what the future may hold regarding regulatory quality requirements for biopharmaceuticals. …

Article Leveraging Data for Better Biopharmaceutical Process Control
Leveraging Data for Better Biopharmaceutical Process Control The need to improve and understand processes is moving PAT and more advanced control strategies beyond the lab into manufacturing and dow…

Article Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Manufacturing Standards Key to Advancing Cellular and Gene Therapies FDA works with industry on strategies for assuring high-quality regenerative medicines. By Jill Wechsler …

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