CDER Small Business and Industry Assistance (CDER SBIA) Webinar on Postapproval Changes Related to Drug Product Quality, Manufacturing and Controls that may be Documented in Annual Reports, May 12, 2014
The Food and Drug Administration, Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA) is pleased to inform you of a unique opportunity for small business entities to learn more about the FDA and basic drug regulation. Our webinar series highlights various aspects of drug regulation.
These focused webinars support the CDER SBIA’s mission of promoting productive interaction with regulated industry by assisting small pharmaceutical business and industry with information relating to the development and regulation of human drug products.
On Monday May 12, 2014, CDER Small Business and Industry Assistance (CDER SBIA) presented a webinar entitled Postapproval Changes Related to Drug Product Quality, Manufacturing and Controls that may be Documented in Annual Reports.
On March 4, 2014, FDA/CDER published its “Guidance for Industry on CMC Postapproval Manufacturing Changes to be Documented in Annual Reports.” This guidance provides recommendations to holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding the types of changes to be documented in annual reports. Specifically, the guidance describes chemistry, manufacturing, and controls (CMC) postapproval changes that the FDA has determined will likely have a minimal potential to adversely affect the approved product quality and, therefore, should be documented by applicants in an annual report.
The guidance lists examples in the following categories of CMC postapproval manufacturing changes previously submitted under manufacturing supplements that the FDA has determined generally to be of low risk to product quality:
- components and composition of the drug product:
- manufacturing facilities
- manufacturing process, batch size, and equipment
- changes in the specification of drug product and its components
- changes in the container/closure system of the drug substance and/or drug product
- labeling changes to revise information related to CMC changes discussed in the guidance, and
- miscellaneous changes related to the stability testing of drug substances and drug products.
This guidance will facilitate the reporting of such changes, thereby leading to a proportional reduction in the number of supplements submitted to the Agency.
Rajendra (Raj) Uppoor, R.Ph., Ph.D.
Pharmacist and Acting Team Leader, OPS IO ANDA CBE Supplements Review Team
Program Activities Review Staff, HFD-003
Office of Pharmaceutical Science
Center for Drug Evaluation and Research (CDER), FDA
Raj Uppoor is a pharmacist and serves as an acting team leader of the ANDA CBE Supplements Review Team in the Program Activities Review Staff of the Office of Pharmaceutical Science, CDER, FDA. He has a Ph.D. degree from the Medical University of South Carolina, Charleston, South Carolina; is a licensed pharmacist in the State of Maryland; and is a holder of Certified Quality Auditor certification by the American Society for Quality.
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