Manufacturers of drug products and container/delivery systems must comply with ever-changing governmental regulations (e.g., US FDA) and industry guidances (e.g., USP). Understanding the nature of these regulations/guidances, and their future direction, is essential to long-term compliance. This section presents papers on these topics.
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This presentation discusses how changes in products, processes and components may impact risk of elemental impurities in drug products, and the subsequent effect on lifecycle management. <p><em>P. Walsh (Merck & Co., Inc.) PQRI/USP Elemental Impurities Workshop (November 2016)</em></p>
<p>This presentation considers the assessment of risk of impurities in a parenteral drug product from various sources: equipment, water, gases, excipients, drug substances, and container closure systems.</p> <p><em>J. Mason (Eli Lilly and Company). PQRI/USP Elemental Impurities Workshop (November 2016)</em></p>
<p>This presentation discusses FDA’s approach to consideration of critical factors in controlling elemental impurities: timelines, documentation, GMP expectations, and methods validation.</p> <p><em>D. Christodoulou (CDER/OPQ Office of New Drug Products). PQRI/USP Elemental Impurities Workshop (November 2016)</em></p>
This article discusses ICH Q3D (Guideline for Elemental Impurities) as it relates to evaluations for impurities in drug products – specifically advocating a risk-based approach. Recommended analytical methods and new thresholds for selected metals are also discussed. <p><em>A. Teasdale, et al. Pharmaceutical Technology, 39 (3), 36-49 (2015)</em></p>
This presentation reviews the basic concepts of two vehicles critical in the pharmaceutical industry: Drug Master File (DMF) and Letter of Authorization (LOA). A DMF is a submission of information to the FDA to permit the FDA to review said information in support of a third party's application without revealing the information to the third party. DMF's usually cover the chemistry, manufacturing and controls of a components of a drug product (e.g., drug substance, excipient, packaging material). An LOA is a document issued by the DMF submitter to the third party authorizing FDA to review DMF and third party to incorporate DMF information by reference in an application. <p><em>Arthur Shaw, FDA DMF Expert</em></p>
This article briefly reviews different regulations applicable to North America regarding environmental mapping of drug products. <p><em>B. McDuffie. Pharmaceutical Online (2017)</em></p>
<em> </em>This presentation gives an overview of the types of analytical methodologies, and sample preparation techniques, that are useful in identifying elemental impurities. <br /> <br /> D. McClenathan (The Procter and Gamble Company). PQRI/USP Elemental Impurities Workshop (November 2016) <br /> <br /> Website for PQRI conference (included here for reference) <br /> http://pqri.org/httppqri-orgpqriusp_workshop_2016-presentations/ <br />
<p>This presentation addresses FDA's view on how effectiveness of a drug product through its life cycle depends upon quality of manufacturing and packaging. Critical areas are: methods, machines, materials, measurements, environment, and people. Numerous examples are given of problems resultant from failure to manage these areas properly.</p> <p><em>Richard Freeman Deputy Director, Science and Regulatory Policy, Office of Manufacturing Quality</em></p>