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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 ]
GAMP itself was founded in 1991 in the United Kingdom to deal with the evolving U.S. Food and Drug Administration expectations for good manufacturing practice (GMP) compliance of manufacturing and related systems. [4] GAMP published its first guidance in 1994.
The quality profession grew from simple control to engineering, to systems engineering. Quality control activities were predominant in the 1940s, 1950s, and 1960s. The 1970s were an era of quality engineering and the 1990s saw quality systems as an emerging field.
The GAMP 5 standard recommends an approach to the creation of the plan. [3]Topics commonly covered include: Introduction, scope, responsibilities, description of facility and design, building and plant Layout, cleanrooms and associated controlled environments, storage areas, personnel, personnel and material Flow, water and solid waste handling, infrastructure and utilities, water system ...
GxP is a general abbreviation for the "good practice" quality guidelines and regulations. The "x" stands for the various fields, including the pharmaceutical and food industries, for example good agricultural practice, or GAP. A "c" or "C" is sometimes added to the front of the initialism. The preceding "c" stands for "current."
"Good Manufacturing Practices (GMP) relate to quality control and quality assurance enabling companies in the pharmaceutical sector to minimize or eliminate instances of contamination, mix-ups, and errors. This in turn, protects the customer from purchasing a product which is ineffective or even dangerous."
Quality inspector in a Volkseigener Betrieb sewing machine parts factory in Dresden, East Germany, 1977. Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "a part of quality management focused on fulfilling quality requirements". [1]
Quality management, therefore, uses quality assurance and control of processes as well as products to achieve more consistent quality. Quality control is also part of quality management. What a customer wants and is willing to pay for it, determines quality. It is a written or unwritten commitment to a known or unknown consumer in the market.