¶ … Manufacturing Practices
What is meant by a "risk-based approach" to GMPs?
What is meant by a risk-based approach to Good Manufacturing Practices (GMPs) is that the Food and Drug Administration (FDA) is undertaking a program and enterprise to make use of a science-based risk management and incorporated quality systems method to pharmaceutical Good Management Practices. In particular, this new-fangled attitude to GMPs planned by means of the science-based risk management tactic will institute a system that aids patients by guaranteeing product quality and offers backings to product obtainability. It is also a system that inspires scientific and inventive developments, and eliminates partiality that presently subsists in a number of areas. Most of all, it resolves decisions made by the FDA with those that manufacturers have to make regarding products, instead of linking GMP to a theoretical number of requirements (Pharma Technologist, 2005). The main purpose or fundamental perspective for undertaking risk-based decision encompasses the risk to patients. Good manufacturing practice guidelines centered on the value of risk-based decisions will include the need for analyzing products on the basis of the threats to health, with all this examined in the process of manufacturing the products (Pharma Technologist, 2005).
What are the most important consequences...
For starters, pharmaceutical manufacturers will be reinvigorated to the prompt implementation of new technological improvements, in so doing, aiding industry use of contemporary quality management practices, including carrying out of quality systems tactics, and boosting application of risk-based approaches that lay emphasis on vital areas. Another aspect is that in the carrying out of the risk-based approach, manufacturing inspection will be given weight and priority, which in turn will bring about decision making that is risk based on a practical, everyday level, all the way through the manufacturing location (Rodriguez, 2008). Another outcome is that the approach will make certain and guarantee that regulatory assessment and inspection strategies are based on advanced and ultramodern pharmaceutical science. One other aspect is that it will improve the reliability and dexterity of FDA's drug quality regulatory agendas and initiatives, to some extent, by incorporating improved quality systems methods into the Agency's commercial practices and regulatory policies regarding evaluation and checkup undertakings. In addition, there is the outcome that it will facilitate industry use of up-to-date quality management methods, as well as carrying out of quality systems tactics, to all features of pharmaceutical…
Ayers (2000, p. 4) describes a supply chain as "Life cycle processes supporting physical, information, financial, and knowledge flows for moving products and services from suppliers to end-users." A supply chain can be short, as in the case of a cottage industry, or quite long and complex as in the manufacture, distribution, and sales of automobiles. In fact, the automobile supply chain has its origin in the mining of the
The use of Radio Frequency Identification (RFID) on individual chocolate packing is making it possible to know item-level inventory positions within the largest retailers for example including Wal-Mart, an early adopter of this technology (Zhou, 2009). The use of RFID is also excellent at managing traceability of specific lots or delivery portions of chocolate (Pacyniak, 2006). With the many quality management concerns within the industry as a result of
Corporate Mergers and the Public Good The United States of America, during the last years of the Nineteenth Century, witnessed a rash of corporate mergers. The Industrial Revolution had taken firm hold, and the nation was changing rapidly. Millions of Americans who had once been independent farmers or tradesmen now found themselves in the position of what some termed "wage slaves." At the mercy of their corporate employers, they worked long
Manufacturing Seven Key Elements for Successful Implementation Norman Binette, Jr. Biddeford, Maine Manufacturing organizations are built on the premise that they possess the ability to provide a wide variety of quality products for their customers. This reputation is dependent upon the constant review of existing processes and the identification of new and innovative methods of production that will enhance and increase the diversification of product lines. One such process that has proven itself
Supply Chain Technologies and Collaboration / Supply Chain Analysis: Coca Cola, DHL, Amazon and John Deere Company Supply chain management implies managing the movement of services and goods. It covers raw material storage and flow, inventory of work-in-process, and movement of finished products from the point of manufacture to the consumption point (Blanchard, 2010). This paper will review four firms, namely, Coca Cola, Amazon.com, John Deere, and DHL, for understanding their
duty-based or deontological ethics will be defined and applied to Mattel Inc.'s case. Duty-Based Ethics Duty-based or deontological ethics deals with what individuals do, rather than the outcomes of their doings. Its key tenets are: Do what is ethically right. Do it since it's ethically right. Refrain from doing wrong things. Refrain from doing them since they're wrong. Under deontological ethics, one cannot simply validate one's actions by proving that its end result was good; thus,