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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.
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.
Meaning [1] Latin (or Neo-Latin) origin [1] a.c. before meals: ante cibum a.d., ad, AD right ear auris dextra a.m., am, AM morning: ante meridiem: nocte every night Omne Nocte a.s., as, AS left ear auris sinistra a.u., au, AU both ears together or each ear aures unitas or auris uterque b.d.s, bds, BDS 2 times a day bis die sumendum b.i.d., bid, BID
The 800 series are for medical devices: 803 Medical device reporting; 814 Premarket approval of medical devices [3] 820 et seq. Quality system regulations (analogous to cGMP, but structured like ISO) [4] 860 et seq. Listing of specific approved devices and how they are classified; The 900 series covers mammography quality requirements enforced ...
This is a list of roots, suffixes, and prefixes used in medical terminology, their meanings, and their etymologies. Most of them are combining forms in Neo-Latin and hence international scientific vocabulary. There are a few general rules about how they combine.
The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide ...
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.