Honors Program
Document Type
Thesis
Date of this Version
2020
Citation
Mills, R.N. 2020. Pharmaceutical Manufacturing in the 21st Century: Identification and Analysis of Key Elements. Undergraduate Honors Thesis. University of Nebraska-Lincoln.
Abstract
The availability of quality pharmaceutical products impacts the lives of the global population on a daily basis. The importance of product availability and quality within pharmaceutical manufacturing requires that quality systems put into place are capable of accurately and robustly capturing the quality compliance, or lack thereof, of the various stages of production. This review intends to analyze current expert-recommended best practices within key elements of a pharmaceutical manufacturing quality control system and provide recommendations throughout. The quality elements discussed include Quality by Design method validation, necessary equipment determination, and equipment qualification, followed by documentation control and data flow.
Included in
Management Sciences and Quantitative Methods Commons, Pharmaceutical Preparations Commons, Pharmacy Administration, Policy and Regulation Commons, Process Control and Systems Commons
Comments
Copyright Robert N. Mills 2020.