| This thesis presents the theory of Lean Thinking and applies the processes and techniques identified for manufacturing operations to pharmaceutical quality systems under the Food and Drug Administration (FDA) regulation. The FDA is defined as the customer. The product is defined as the deliverables required by the FDA of the quality systems to ensure compliance with the applicable laws, regulations, and guidance documents.;The evolution of the FDA is examined to understand its intent in protecting the drug consumer, increasing authority, increasing enforcement capabilities, current expectations of pharmaceutical manufacturers, and the cost of non-compliance. The evolution of Lean Thinking is also examined. The five key principles of Lean Thinking: value definition, value stream identification, flow, pull, and perfection are extrapolated to pharmaceutical quality systems. This extrapolation results in a detailed identification of the quality systems components, their associated responsibilities, and the value streams necessary to ensure compliance. |
