Abstract
In this whitepaper, the Manufacturing Technical Committee of the Product Quality Research Institute provides information on the common, best practices in use today in the development of high-quality chemistry, manufacturing and controls documentation. Important topics reviewed include International Conference on Harmonization, in vitro–in vivo correlation considerations, quality-by-design approaches, process analytical technologies and current scale-up, and process control and validation practices. It is the hope and intent that this whitepaper will engender expanded dialog on this important subject by the pharmaceutical industry and its regulatory bodies.
Highlights
In 1991–1992, three scientific organizations—the American Association of Pharmaceutical Scientists, the Food & Drug Association (FDA), and the United States Pharmacopeia (USP)—collaborated to organize two workshops to explore the Scale-Up and Post-approval Change (SUPAC) principles for (1) immediate-release oral solid dosage forms (1991) and (2) oral extended-release dosage forms (1992).Proceedings from both workshops were published in 1993 (1,2) and have been used as guidance to the industry and regulatory bodies
We review modernization of those techniques and the testing equipment used to monitor in vitro drug release, with an end goal of facilitating the development of in vivo correlation (IVIVC) that can be used to expedite post-approval changes
Other than for minor editorial changes such as spelling corrections or reformatting batch records, etc., the applicant must notify the FDA about each change that is made beyond the range that is allowed for that change in the approved application (Section 314.70(a)(1))
Summary
In 1991–1992, three scientific organizations—the American Association of Pharmaceutical Scientists, the Food & Drug Association (FDA), and the United States Pharmacopeia (USP)—collaborated to organize two workshops to explore the Scale-Up and Post-approval Change (SUPAC) principles for (1) immediate-release oral solid dosage forms (1991) and (2) oral extended-release dosage forms (1992). These documents continue to have utility in supporting post-approval changes, it has been recognized that there have been many improvements implemented in the scale-up and control of both immediate-release and extended-release oral solid dosage forms in the last two decades It is the goal of the authors of this whitepaper to provide a concise updating of important development principles currently available to those in the industry involved in the development of such products. In addition to providing a brief review of all of the major tools in place today that are useful to the pharmaceutical scientist involved in the development of immediate- and extended-release oral solid dosage forms, our whitepaper contributors have included brief commentary on what they see as developing trends that could bring new exciting tools to bear on these issues in the 3–5 years. Several guidance documents have been issued by non-US regulatory agencies [e.g., EC communication on variations (3) and Health Canada guidance on post-notice of compliance (NOC) changes (4)] that offer valuable insight into the regulatory pathways (ex-US) to submitting post-approval changes
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