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Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages , [ 1 ] cosmetics , [ 2 ] pharmaceutical products , [ 3 ] dietary supplements , [ 4 ] and medical devices . [ 5 ]
A standard specification is an explicit set of requirements for an item, material, component, system or service. It is often used to formalize the technical aspects of a procurement agreement or contract. [2] For example, there may be a specification for a turbine blade for a jet engine that defines the exact material and performance requirements.
Design for environmental processing and manufacturing: Raw material extraction (mining, drilling, etc.), processing (processing reusable materials, metal melting, etc.) and manufacturing are done using materials and processes which are not dangerous to the environment or the employees working on said processes. This includes the minimization of ...
More specifically, the ISPE's guide The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. One of the core principles of GAMP is that quality cannot be tested ...
Parts can be designed for additive manufacturing by eliminating or reducing the need for temporary support structures. This can be done by limiting the angle of overhanging structures to less than the limit of the given additive manufacturing machine, material, and process (for example, less than 70 degrees from vertical).
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Quality by design (QbD) is a concept first outlined by quality expert Joseph M. Juran in publications, most notably Juran on Quality by Design. [1] Designing for quality and innovation is one of the three universal processes of the Juran Trilogy, in which Juran describes what is required to achieve breakthroughs in new products, services, and processes. [2]
Unlike the names in the list above, these names are still widely known by the public as brand names, and are not used by competitors. Scholars disagree as to whether the use of a recognized trademark name for similar products can truly be called "generic", or if it is instead a form of synecdoche .