Glossary

Standard Generalized Markup Language

An agitated suspension in culture providing adequate aeration for cells in the liquid medium. Usually an Erlenmeyer flask containing the culture is attached to a horizontal or platform shaker, or agitated with a magnetic stirrer.

Putting a system or systems into operation, knowing inspection, adjustment, regulation, and testing of the system may be less than complete, having first ensured that it is safe and responsible to do so (e.g., the system will not be damaged, or cause damage, or cause death or injury if operated). The purpose of the shake-down is to rapidly reveal and remedy deficiencies prior to commencement of a formal change control regime within a qualification and-or a commissioning effort.

Safety, Health, Environment

1. The sliding of one layer across another, with deformation and fracturing in the direction parallel to the movement. This term usually refers to the forces that cells are subjected to in a bioreactor or a mechanical device used for cell breakage.2. To fragment DNA molecules into smaller pieces. DNA, as a very long and fairly stiff molecule, is very susceptible to hydrodynamic shear forces. Forcing a DNA solution through a hypodermic needle will fragment it into small pieces. The size of the fragments obtained is inversely proportional to the diameter of the needle's bore. The actual sites at which the shear force breaks a DNA molecule are approximately random. Therefore DNA fragments may be generated by random shear and then cloned (by either tailing their ends or using linkers) so as to create a complete gene library of an organism. This method is little used now, having been replaced by the use of partial digests with four-base-pair cutters, such as Sau3A, as a means of generating random DNA fragments.

The period of time during which a drug can be stored without decreasing in quality, safety, or efficacy.

(ICH Q1A (R2)) The time period during which a drug product is expected to remain within the approved shelf life specification, provided that it is stored under the conditions defined on the container label.

An arc welding process that produces coalescence of metals by heating them with an arc between a covered metal electrode and the work. Shielding is obtained from decomposition of the electrode covering. Pressure is not used and filler metal is obtained from the electrode.

Protective gas used to prevent atmospheric contamination of the weld pool.

Sequencing method that involves randomly sequencing tiny cloned pieces of the genome, with no foreknowledge of where on a chromosome the piece originally came from. This can be contrasted with “directed” strategies, in which pieces of DNA from adjacent stretches of a chromosome are sequenced. Direct strategies eliminate the need for complex reassembly techniques. Because there are advantages to both strategies, researchers expect to use both random (or shotgun) and directed strategies in combination to sequence the human genome.

Breaking DNA into many small pieces, sequencing the pieces, and assembling the fragments.

Silicone

An inherited, potentially lethal disease in which a defect in hemoglobin, the oxygen-carrying pigment in the blood, causes distortion (sickling) and loss of red blood cells, producing damage to organs throughout the body.

An unintended alteration of a program's behavior caused by a change in one part of the program, without taking into account the effect the change has on another part of the program.

Undesired effect of a treatment. Investigational new drugs and devices are evaluated for immediate and long-term side effects.

The SI unit of ionizing radiation.

Special Interest Group (of the GAMP Forum)

The biochemical events that conduct the signal of a hormone or growth factor from the cell exterior, through the cell membrane, and into the cytoplasm. This involves a number of molecules, including receptors, ligands and messengers.

(ICH Q7)