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In most countries, a marketing authorisation is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorisation, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable.
A centralised marketing authorisation, issued by the European Commission, allows the holder to market a medicinal product throughout the European Economic Area (EEA), which comprises the EU Member States, Iceland, Norway and Liechtenstein. [2] In the United States, the equivalent process is called New Drug Application.
Material requirements planning (MRP) is a production planning, scheduling, and inventory control system used to manage manufacturing processes. Most MRP systems are software-based, but it is possible to conduct MRP by hand as well. An MRP system is intended to simultaneously meet three objectives:
A market requirements document (MRD) in project management and systems engineering, is a document that expresses the customer's wants and needs for the product or service. [1] [2] It is typically written as a part of product marketing or product management. The document should explain: What (new) product is being discussed; Who the target ...
A product requirements document (PRD) is a document containing all the requirements for a certain product. It is written to allow people to understand what a product should do. A PRD should, however, generally avoid anticipating or defining how the product will do it in order to later allow interface designers and engineers to use their ...
Manufacturing resource planning (MRP II) [1] is a method for the effective planning of all resources of a manufacturing company. Ideally, it addresses operational planning in units, financial planning, and has a simulation capability to answer "what-if" questions and is an extension of closed-loop MRP (Material Requirements Planning). [2]
A master production schedule (MPS) is a plan for individual commodities to be produced in each time period such as production, staffing, inventory, etc. [1] It is usually linked to manufacturing where the plan indicates when and how much of each product will be demanded. [2]
BPCS includes MRP logic to manufacturing operations, provided there are high standards of data validity such as engineering specifications and inventory accuracy. It runs on several systems, with IBM I, being the most popular. It is written in AS/SET CASE tool, RPG, SQL and other languages supported on IBM I. [3]