Glossary

A computerized system deployed at more than one location that is managed centrally. The degree of centralized control can vary to a great extent.

The individual with final accountability for the performance and compliance of the overall global system. Responsibility for executing the associated activities is normally delegated.

A gradual increase in the overall temperature of the earth's atmosphere generally attributed to the greenhouse effect caused by increased levels of carbon dioxide, chlorofluorocarbons, and other pollutants.

Common proteins in blood, eggs and milk, and as a reserve protein in seeds. Globulins are insoluble in water, but soluble in salt solutions. Alpha, beta and gamma globulins can be distinguished in blood serum. Gamma globulins are important in developing immunity to diseases.

Component of an access device that maintains an effective barrier while enabling the hands of the operator to enter the enclosed volume of a separative device.

Attachment site for gloves, sleeves and gauntlets.

Multi-component access device that maintains an effective barrier while enabling replacement of the sleeve piece, connecting cuff piece and the glove.

An Engineering Control that provides containment by separating the process from the operator and environment in a sealed microenvironment. These systems can operate under negative, positive or ambient pressure and can be designed with laminar airflow, turbulent airflow or no airflow (passive system)

Good Laboratory Practice

They are codes of practice designed to reduce to a minimum the chance of accidents which could affect a research project or a manufactured product. The GLP and GMP prescriptions are quite voluminous, but boil down to a few key points. The essential point of both GLP and GMP is that everything is recorded, and that only established procedures are used and by people who have been trained to use them.

Good Large-Scale Practice

A mixture of two proteins, gliadin and glutenin, occurring in the endosperm of wheat grain. Their amino acid composition varies, but glutamic acid (33%) and proline (12%) predominate. The composition of wheat glutens determines the strength of the flour and whether or not it is suitable for biscuit or bread making. Sensitivity of the lining of the intestine to gluten occurs in celiac disease, a condition that must be treated by a glutenfree diet.

A protein conjugated with a carbohydrate group.

Adding one or more carbohydrate molecules onto a protein (a glycoprotein) after it has been built by the ribosome; a posttranslational modification.

Gas Metal-Arc Welding

General Medical Council (United Kingdom)

Granulocyte-Macrophage Colony Stimulating Factor

Genetically Modified Organism

Good Manufacturing Practice

A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. The main risks are:a)Unexpected contamination of products, causing damage to health or even death.b)Incorrect labels on containers, which could mean that patients receive the wrong medicine.c)Insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects.GMP covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made.WHO has established detailed guidelines for good manufacturing practice. Many countries have formulated their own requirements for GMP based on WHO GMP. Others have harmonized their requirements, for example in the Association of South-East Asian Nations (ASEAN), in the European Union and through the Pharmaceutical Inspection Convention.Who GMP Guidelines - Quality Assurance of Pharmaceuticals – A compendium of guidelines and related materials – Volume 2: Good manufacturing practices and inspectionIntroduction 1. WHO GMP: main principles for pharmaceutical products Quality managementGood practices in production and quality controlValidation of manufacturing processesAuthorized person-role, functions and training2. Good manufacturing practices: starting materialsActive pharmaceutical ingredients (bulk drug substances)Pharmaceutical excipients3. Good manufacturing practices: specific pharmaceutical productsBiological productsInvestigational pharmaceutical products for clinical trials in humansHerbal medicinal products4. InspectionInspection of pharmaceutical manufacturersInspection of drug distribution channels

Regulations of the FDA and comparable non-US agencies that describe the minimum standards for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packaging, or holding a drug, to assure that such drugs meet the requirements of the Act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to posses.

A GMP or product quality parameter.