Glossary

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A base sequence in a DNA molecule (or an amino acid sequence in a protein) that has remained essentially unchanged throughout evolution.

(IEEE) The degree of uniformity, standardization, and freedom from contradiction among the documents or parts of a system or component.

A software tool used to test requirements in design specifications for both consistency and completeness.

A value that does not change during processing.

Gene expression that results in cell death.

(IEEE) Evaluation of the safety of restrictions imposed on the selected design by the requirements and by real world restrictions. The impacts of the environment on this analysis can include such items as the location and relation of clocks to circuit cards, the timing of a bus latch when using the longest safety-related timing to fetch data from the most remote circuit card, interrupts going unsatisfied due to a data flood at an input, and human reaction time.

Verification that the program operates within the constraints imposed upon it by requirements, the design, and the target computer. Constraint analysis is designed to identify these limitations to ensure that the program operates within them, and to ensure that all interfaces have been considered for out-of-sequence and erroneous inputs.

Review of the detail as to how a project will be constructed for the purpose of assessing improved or value added alternatives for the delivery of the construction phase of the project.

2D/3D drawings of all systems, schedules, details, dimensions, notes, references, etc. Many of these drawings are “red lined” during the construction phase and updated at project completion. Many of these drawings are then kept up to date for maintenance, safety or GMP reasons.

A ring of metal placed between the two elements to be welded that provides filler for the weld, when performed with fusion welding equipment. A consumable insert can also be used for the root pass in a multiple pass weld with the addition of filler wire.

Compared to a Medication Guide, a Consumer Medication Information sheet offers broader information on how to use a medicine. CMI sheets are not developed or regulated by FDA. These information sheets are prepared by pharmacies and given out with prescription drugs. CMI sheets are not available on the FDA Web site. The sheets help consumers understand key information about their prescription medicine, including how to take it, how to store it, and how to monitor their treatment. The sheets also include information on precautions and warnings, as well as symptoms of serious or frequent adverse events and what to do if you experience one.

Specially designed container holding an appropriate, sterile, culture medium with an accessible surface used for surface sampling. ISO 14698-1.

Contact device where the container is a rigid dish. ISO 14698-1.

A hydrophobic membrane used in removing dissolved gases from water.

An area constructed and operated in such a manner (and equipped with appropriate air handling and filtration) so as to prevent contamination of the external environment by biological agents from within the area.

Specific manufacturing space constructed and equipped with appropriate air handling and filtration and operated to prevent contamination of theexternal work environment.

(ICH Q1A (R2)) The sum of packaging components that together contain and protect the dosage form. This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection to the drug product. A packaging system is equivalent to a container closure system.

The sum of packaging components that together contain and protect the drug product. This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection to the drug product, or dug product primary container.

(EMEA - CHMP) The sum of packaging components that together contain and protect the active substance or the dosage form. This includes immediate packaging components and secondary packaging components, if the latter are intended to provide additional protection to the active substance or the drug product.

A listing of randomized identification numbers across the different treatment groups in a protocol or grouping of protocols. Use to associate a container to a particular treatment group as defined by the subject randomization.

A receptacle for holding and/or transferring material. In the case of Active Pharmaceutical Ingredients (APIs) and in-process drug products, the most common containers are fiber drums with plastic liners. Bottles, glass vials, films, and foils used in packaging drugs are also containers. In the case of laboratory materials, containers include plastic or glass receptacles.