Product life cycle manufacturing process

Within the broad framework of sustainable development, we should strive to maximize resource efficiency through activities such as energy and nonrenewable resource conservation, risk minimization, pollution prevention, minimization of waste at all stages of a product life-cycle, and the development of products that are durable and can be re-used and recycled. Sustainable chemistry strives to accomplish these ends through the design, manufacture and use of efficient and effective, more environmentally benign chemical products and processes". 

Reactive chemical process safety Systematic identification, evaluation, and control of reactive hazards at all phases of the production life cycle-from R D to pilot plant, change management, and decommissioning and for all types of operations-from storage or manufacturing to packaging or waste processing. 

The QMS and the processes that comprise it must be custom designed for the needs of the business. One size does not fit all situations. The requirements of an enterprise vary across sites and the phases of a product life cycle. A comprehensive system will ensure a holistic programmatic approach in its support to the enterprise. This does not mean that every phase of the product life cycle (discovery, development, commercial manufacturing) will utilize all the processes that comprise the system. Nor does it require that all commercial manufacturing sites will necessarily implement all processes. It does, however, provide a common platform and expectation for all processes, owners, metrics review programs, continuous improvement efforts, and the like when they are implemented. 

The manufacturing department ships the product in accordance with manufacturing guidelines, based on the receipt of valid purchase orders. The product documentation includes a Declaration of System Validation with statements from Hewlett-Packard that the software was developed and tested according to the Hewlett-Packard Analytical Software Life Cycle, a process that has been certified for ISO 9001 quality standard and for the information technology quality system (ITQS) compliance and that has been inspected by representatives from both computer validation companies and the pharmaceutical industry. 

Various strategies are pursued by pharmaceutical companies to extend the product life cycle. Under the Hatch-Waxman Act, patent term extensions are available for patented drug substances, drug products, method of use, and method of manufacturing to compensate for the time lost in the FDA s regulatory approval process. However, the limitations of the statute of the following aspects have to be considered ... 

The manufacture of a chemical product within a chemical processing plant is one stage of a product life cycle that includes the entire manufacturing and product assembly chain, as well as the use and disposal phases of the product. It is important to minimize the waste in the entire product life cycle, implying waste... 

Promoting the sustainable development implies the availability of reliable measures. These measures should regard the complete manufacturing-supply chain over the predictable product life cycle. The metrics should be simple and understandable by the large public, useful for decision-making agents, consistent and reproducible. The sustainability measures proposed recently by Schwartz, Beloff Beaver (2002) have these properties. They refer to the same unit of outputs, for example the to the value-added dollar Fy4, defined as Revenues minus Costs of raw materials and utilities. The metrics that will be presented are consistent in the sense that 1) the lower the metric the more effective the process, and 2) all indicate the same direction. 

Validation maintenance, an ongoing activity for manufacturing processes [11], continues through the life cycle of the process with a changing focus as the process matures [20]. There is a need to address the process life cycle as a whole and not to suspend process validation after three production scale runs are completed [14]. To support this life-cycle approach, process expert teams are created to rapidly resolve process deviations, determine trends toward loss of control, comply with regulatory requirements, assess process change impact, and identify areas for process improvement [11]. 

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