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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Regulations regarding elemental impurities in drug products have changed. Consistent with a focus on patient safety – West has remained ahead of these changes and developed the methods needed to help customers comply with them – whatever the stage of drug product development. Pharmacopoeia address certain requirements for the quality, safety and efficacy of marketed products which are country specific. This can be problematic because methods and specifications in compendia will be somewhat different and challenging to navigate depending on the requirements in both mature and emerging markets. Committed to the safest and most efficient delivery of drug products, West monitors these regulations continually to stay ahead of changes, and maintains the staff, expertise and facility to design, and perform, the studies needed to help Customers comply.
The US Food and Drug Administration (FDA) recently issued a draft guidance: Comparative analyses and related comparative use human factor studies for a drug-device combination product submitted in an ANDA, January 2017. This guidance is intended to assist potential applicants who plan to develop and submit an abbreviated new drug application (ANDA) to seek approval of a proposed combination product, that include a drug and a delivery device intended to administer a drug product.
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>
December 20, 2017 the EU GMP Annex 1 Draft was released for public comment. When completed, this document will set standards for good manufacturing practices for drug products and drug substances. It was published first in 1971, and had last seen revision in 2008. This latest version in particular addresses quality risk management as well as new technologies and procedures.
<p>This presentation gives an overview of the types of analytical methodologies, and sample preparation techniques, that are useful in identifying elemental impurities.</p> <p><em>D. McClenathan (The Procter and Gamble Company). PQRI/USP Elemental Impurities Workshop (November 2016)</em></p> <p>Website for PQRI conference (included here for reference)<br /> http://pqri.org/httppqri-orgpqriusp_workshop_2016-presentations/<em><br /> <div> </div> </em></p>
<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>