A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Gang-printed labeling

Labeling derived from a sheet of material on which more than one item of labeling is printed.

Generic Drug Product

A generic drug product is an off patent drug product with the same strength and dosage but other brand as the drug product. Not all components must be necessarily identical.

or

A broad term for chemically equivalent drugs that are available from multiple manufacturers. Commonly used to refer to products, other than then innovator’s, that are sold under the universal chemical name for the drug.

GMP Document

A GMP documents can be any written record associated with the manufacture and control or distribution of the Drug Substance / Active Pharmaceutical Ingredient (API) or drug product.

GMP Training

GMP training is defined as a documented and assessed GMP training that can be both, general GMP/Quality as well as job specific.

GMP-Quality Training Assessment

A GMP - Quality training assessment assesses formally the training. This assessment should track on the one hand the training requirements of the personnel and on the other hand should record the attendance and successful fulfilment and understanding of the training course content.

Good Clinical Practice-GCP

The Good Clinical Practice (GCP) is applicable for clinical trials and should assure that generated data, results and conclusions are accurate and credible. GLP includes but is not limited to the design, conduct, performance, monitoring, auditing, recording and analyzing of clinical trials.

or

An international ethical and scientific quality standard for the design, conduct and record of research involving humans. The principles of GCP are outlined in EU Directive 2005/28/EC

Good Laboratory Practice-GLP

The Good Laboratory Practices are predefined, common criteria, which should be addressed as a basis for validating results and conclusions generated in pre-clinical laboratory studies. GLP defines a recognized standard for the management of laboratory studies and results that gives transparent and comprehensible evidence of what has been done.

Good Manufacturing Practice-GMP

The Good Manufacturing Practice (GMP) or the current Good Manufacturing Practices (cGMP) are the minimum criteria and expectations to be met to assure that a drug meets the requirements of the regulations as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess. The GMPs are applicable for e.g. methods, facilities and controls, the manufacture, processing, testing, packaging or holding of a drug.

Grit

In reference to the polishing of stainless steel pipe:
Grit is one method of determining or specifying a degree of smoothness or surface roughness required. Initially a desired smoothness for the inside or outside of pipe was specified in polish numbers such as #4 or #7. However, this system of specifying surface roughness provided for too broad a range of roughness. Grit numbers have essentially replaced polish numbers in an effort at providing more specific requirements. For example: a #4 polish could vary from an 80 grit to a 150 grit finish; a #7 polish could vary from a 180 grit to a 320 grit finish. The industry is now adopting an even more specific method of determining surface roughness. The surface is specified in micro inches or microns and measured with a profilometer. The surface roughness is measured or specified as either of two arithmetic derivations: Rq – root mean square or Ra – arithmetic mean. In utilizing a quantitative measuring technique, all of the variables inherent in polishing are eliminated. An end user can now specify a specific surface roughness. For example by specifying 25 m in Ra for a surface roughness the vendor now has to determine the best way to achieve that very specific finish requirement.