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Within quality management systems (QMS) and information technology (IT) systems, change control is a process—either formal or informal [1] —used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. It reduces the possibility that unnecessary changes will be introduced to a system without ...
With this framework – according to Hinz [2] – the FDA tries to motivate the pharmaceutical industry to improve the production process. Because of the tight regulatory requirements and the long development time for a new drug, the production technology is "frozen" at the time of conducting phase-2 clinical trials.
Pharmaceutical manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs as part of the pharmaceutical industry. The process of drug manufacturing can be broken down into a series of unit operations , such as milling , granulation , coating , tablet pressing , and others.
Manufacturing process management (MPM) is a collection of technologies and methods used to define how products are to be manufactured. Product data management (PDM) is focused on capturing and maintaining information on products and/or services through their development and useful life. Change management is an important part of PDM/PLM.
Process validation involves a series of activities taking place over the lifecycle of the product and process.". [4] A properly designed system will provide a high degree of assurance that every step, process, and change has been properly evaluated before its implementation. Testing a sample of a final product is not considered sufficient ...
The four stages of technology life cycle are as follows: [6] Innovation stage: This stage represents the birth of a new product, material of process resulting from R&D activities. In R&D laboratories, new ideas are generated depending on gaining needs and knowledge factors.
Critical process parameters (CPP) in pharmaceutical manufacturing are key variables affecting the production process. CPPs are attributes that are monitored to detect deviations in standardized production operations and product output quality or changes in critical quality attributes .
The R&D pipeline involves various phases that can broadly be grouped in 4 stages: discovery, pre-clinical, clinical trials and marketing (or post-approval). Pharmaceutical companies usually have a number of compounds in their pipelines at any given time. The drug pipeline is an important indicator of the value and future prospects of a company ...