Product Development White Paper: Medical Device & Diagnostic Industry: "Increasing Product Yields with Automated Vision Systems"
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Product quality and production yield go directly to the bottom line. Effective production line quality control inspections are essential to verify quality and detect problems that can lower production yields. Often, manual inspection processes are more effective than automated systems, for example when the product to be inspected is complex, the attributes to be inspected are more qualitative than quantitative, or the cost to develop an automated system is large. This article describes the development of a computer-based system for automated product inspection and quality control. The system was developed to improve yields and eliminate excessive variability that was observed with a manual inspection process.
Product Development White Paper: On-Line Monitoring and Process Analytical Technologies
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Process Analytical Technologies (PAT) are systems which provide continuous on-line monitoring of critical quality parameters and performance attributes of raw and in-process materials. Application of PATs to pharmaceutical manufacturing is an element of FDA's new risk-based approach to regulation described in "GMP's for the 21st Century." This document provides a brief overview of the approach being used to examine and implement PATs in the industry and discusses the roles that MPR can play in this effort.
Product Development White Paper: MPR Rapid Product Development and Commercialization: Case Study on PET Formulation System
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A positron emission tomography (PET) scan is a unique noninvasive imaging technique that is used to produce three-dimensional images of the living heart, brain or other organs at work. PET scans are often used in the diagnosis and management of cancers, certain brain disorders and heart disease because PET has a unique ability to image complex biological functional processes such as blood flow, oxygen consumption, glucose metabolism, tumor metabolic activity and concentrations of various compounds in selected organs. This is significant because in many cases of cancer when it is first diagnosed or if it has been treated with chemotherapy or radiation therapy, the function of the cells will change before there is any evidence of physical change. As such, conventional imaging techniques may have difficulty identifying cancer at an early stage, or determining if therapy is effective based on anatomy alone. Since PET provides physicians with information about the body's chemistry not available through any other procedure, it is positioned as a complimentary imaging tool to anatomic imaging methods such as CT or MRI scans.
Product Development White Paper: Risk-Based Validation of Computer Systems Used In FDA-Regulated Activities
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This document provides a summary of the requirements relating to use of computer-based systems in activities that are regulated by the FDA. The relevant FDA and industry guidance for complying with these requirements is also summarized. Finally, the approach proposed by MPR for system validation/qualification is discussed. The MPR approach uses risk-based prioritization to identify and address the most critical systems and functions first. For complex distributed systems, MPR's approach is to segment the system on a functional basis. This can be used, for example, to divide network systems into functional components that can then be prioritized based on risk and validated.