Quality improvement, through manufacturing

The emphasis in vehicle manufacturing is on using returnable containers to achieve the substantial savings they represent in labor, storage, and warehouse costs. Quality improvement through elimination of dust and similar contamination as well as the improved protection from a returnable system make this a real winner. The system design eliminated the use of cardboard at Bramalea for almost 100% of parts. 

Life cycle management and change control provide a mechanism for continuous improvement. To support continuous improvement through change control a quality system would need to be based on principles of manufacturing science and risk-management. The proposed ICH QIO guidance is an opportunity to accomplish this task. 

Soybean oil has a high linoleic acid content of around 50.8% and 7% of linolenic acid and is thus susceptible to oxidation. Adverse effects caused by oxidation of vegetable oils include loss of essential fatty acids, production of off-flavors and toxic compounds (Sonntag, 1979). The oxidative stability becomes an important quality control parameter for the manufactures and users of vegetable oils. Although the oxidative stability of soybean oil has been greatly improved through the concerted efforts of universities, industries... 

We will comply with NMLs policies and procedures for quality assurance activities. In addition we will develop our own ideas to improve upon NML requirements. We will set quality targets and objectives in line with corporate standards. In support of achieving customer satisfaction we will seek to achieve product conformity by carrying out quality assurance activities at all stages of vehicle manufacture - from planning through to vehicle sales. 

A primary objective of chemical compatibility testing is to ensure that liner materials will remain intact not just during a landfill s operation but also through the postclosure period, and preferably longer. It is difficult, however, to predict future chemical impacts. There is no guarantee that liner materials selected for a site today will be the same as materials manufactured 20 years from now. For example, the quality of basic resins has improved considerably over the last few years. 

The FDA also introduces the concept of process analytical technology (PAT). PAT refers to systems that are used to analyze, monitor, and control manufacturing processes on a continuous basis. The quality attributes and specifications of raw materials, in-process intermediates, and processes are measured in real time and compared with predetermined parameters so that deviations can be rectified in a proactive nature to assure that the end products conform to the level of quality as expected. It is believed that a system based on PAT being implemented in a real-time manner would improve manufacturing efficiency and simultaneously retain or improve the product quality through these interactive measurements and controls. 

Continuous improvement PAT framework provides many options and opportunities including research data collection in production Manufacturing Science WG creating regulatory flexibility through ICH Q8 CGMP initiative objective Product is in specification Acceptance criteria—variable/continuous data Evolutionary, incremental process optimization, continuous, daily activity Carried out by plant and quality staff... 

Quality and productivity improvement share a common element-reduction in variability through process understanding. Reducing variability provides a win-win opportunity from both public health and industry perspectives. And, since pharmaceutical product manufacturing technologies and practices are generally similar between both innovator and generic... 

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