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Glossary
 

Control of Substances Hazardous to Health (COSHH): UK regulations about the handling of chemicals in the workplace. A COSHH form are required to be supplied with any chemicals to where it is delivered and always be available to all members of staff handling it. It contains guidelines on what should be done if the chemical comes into contact with skin and other safety precautions, plus the normal "Irritant", "Flammable" or other chemical and biochemical hazard warnings.

Controlled Documents: All internally generated documents that have been designated as pertaining to the operation of its quality management system. These include all: policies, procedures, work instructions, records, job descriptions, and organizational charts. Externally generated documents that have been designated as impacting upon the operation of its quality management system or affecting product quality. These include: relevant ISO, EN, ANSI and other standards, relevant medical devices regulations, and client–supplied product specifications, drawings, and instructions.

Good Laboratory Practice (GLP): a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for pharmaceuticals, agrochemicals, cosmetics, food and feed additives and contaminants, novel foods and biocides. GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments.

Good Distribution Practice(GDP): Guidelines for the proper distribution of medicinal products for human use. GDP is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs, intended for human consumption. GDP regulates the division and movement of pharmaceutical products from the premises of the manufacturer of medicinal products, or another central point, to the end user thereof, or to an intermediate point by means of various transport methods, via various storage and/or health establishments.

Good Manufacturing Practice (GMP): Regulatory framework governing the control and management of manufacturing and quality control testing of foods and pharmaceutical products. An important part of GMP is documentation of every aspect of the process, activities, and operations involved with drug and medical device manufacture. If the documentation showing how the product was made and tested (which enables traceability and, in the event of future problems, recall from the market) is not correct and in order, then the product does not meet the required specification and is considered contaminated (adulterated in the US). Additionally, GMP requires that all manufacturing and testing equipment have been qualified as suitable for use, and that all operational methodologies and procedures (such as manufacturing, cleaning, and analytical testing) utilized in the drug manufacturing process have been validated (according to predetermined specifications), to demonstrate that they can perform their purported function(s).

Good Automated Manufacturing Practice (GAMP): is a set of guidelines laid down by International Society of Pharmaceutical Engineering (ISPE) covering the use of automated manufacturing and electronic tracking systems within the pharmaceutical industry.

ISO 9000:2000: The International Organization for Standardization models for quality assurance. ISO 9000:2000 is the model for design, development, production, and installation and servicing.

 

 


 
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