Extractables and Leachables

Learn to address the safety aspects of packaged drug products and medical devicesIt is a universal expectation that pharmaceutical drug products and medical devices are effective and safe to use. One aspect of pharmaceutical products and medical devices that impact their safe use is impurities contained within these items, as the patient or user is exposed to these impurities when the drug product is administered or when the medical device is used. Clearly, patient or user exposure must be such that the exposure does not have an adverse impact on the patient's or user's health and safety. Furthermore, these impurities must not be present in such quantities that they adversely affect key quality attributes of the drug product or medical device, including its stability, efficacy, appearance, shelf-life and conformance to standards.Extractables and leachables, derived from the drug product's packaging, manufacturing systems and/or delivery systems or from the medical device's materials of construction, are an important class of such impurities. Thus, it is imperative to understand and quantify the release of extractables from packaging, manufacturing and delivery systems, the accumulation of leachables in drug products, and the release of leachables from medical devices. Once extractables and leachables have been discovered, identified and quantified, it is essential that their effect on the key product or device quality attributes, including safety, be systematically and scientifically established according to recognized, rigorous, and relevant regulatory and compendial standards and industry-driven best practices.In Chemical (Extractables and Leachables) Characterization, the product quality aspects of compatibility (including safe use) for drugs (and their containers, delivery devices and manufacturing systems) and medical devices are examined at length, focusing particularly on how trace-level extractables and leachables affect the quality and safety of a therapeutic product and how to assess the magnitude of the effect. This is done by addressing the two critical activities required to develop, register and commercialize safe, effective and affordable clinical therapies; measuring extractables and leachables (chemical characterization) and assessing their impact (for example, toxicological safety risk assessment). Each of these activities is addressed in-depth, based on the existing and developing international regulations and guidelines, current published literature and the author's extensive personal experience. Written by a key contributor to standards, guidelines, recommended practices and the relevant scientific literature, the book provides "insider" insights beyond what can be gained by merely reading the relevant texts. In addition, given that the extractables-and-leachables landscape has changed dramatically in the last decade, this book provides the reader with the most up-to-date and crucial information on new and forthcoming regulations and best practices.Chemical (Extractables and Leachables) Characterization readers will also find:* A thorough summary of regulatory and compendial guidelines and the steps required to meet them* A detailed and in-depth review of essential scientific principles and recommended best practices for the design, implementation, interpretation and reporting of chemical characterization studies* Sound scientific principles for the design, implementation, and interpretation of chemical characterization studies* A practical resource for industry insiders to rely on to facilitate the development, registration, and commercialization of safe and effective products* A helpful tool to maximize product development and regulatory outcomesChemical (Extractables and Leachables) Characterization is the essential reference for pharmaceutical scientists, analytical chemists, regulatory affairs professionals, engineers, and toxicologists in areas such as product research and development,