Production Regulatory Affairs, Current Good Manufacturing Practice

BTC 2310 3 Quarter Hours
Course Level Undergraduate
Description Designed for degree and nondegree candidates. Presents the history of regulations and current interpretation of those regulations, including the CFRs, points to consider, and U.S. pharmacopoeia. Topics include considerations of implementation, including traceability, documentation responsibilities, personnel and process flow, segregation and labeling of products to prevent cross-contamination, quarantining and testing incoming reagents, in-process testing, sterility testing, environmental monitoring, facility requirements, QC testing, quality assurance functions, batch records, training records, gowning, and validations. Prereq. BTC 3110.

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