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This process is performed within a legal framework defining the requirements necessary for successful application to the regulatory authority, details on the assessment procedure (based on quality, efficacy and safety criteria), and also the circumstances where a marketing authorisation already granted may be withdrawn, suspended or revoked. [1]
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:
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 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.
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]
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 ...
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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 ...