Glossary

(ICH Q1A (R2)) The process of adding together the assay value and levels of degradation products to see how closely these add up to 100% of the initial value, with due consideration of the margin of analytical error.

Median particle diameter based on the particle mass.NOTE: For the mass median, one half of mass of all particles is contributed by particles with a size smaller than the mass median size, and one half by particles larger than the mass median size.

An instrument used to identify chemicals in a substance by their mass and change.

A contract reached between parties, in which the parties agree to most of the terms that will govern future transactions or future agreements. A master agreement permits the parties to quickly negotiate future transactions or agreements, because they can rely on the terms of the master agreement, so that the same terms need not be repetitively negotiated, and to negotiate only the deal-specific terms.

A culture of cells distributed into containers in a single operation, processed together and stored in such a manner as to ensure uniformity and stability and to prevent contamination. A master cell bank (master cell seed) is usually stored at -70°C or lower.

(ICH Q5A (R1)/Q5B/5QD) An aliquot of a single pool of cells which generally has been prepared from the selected cell clone under defined conditions, dispensed into multiple containers and stored under defined conditions. The MCB is used to derive all working cell banks. The testing performed on a new MCB (from a previous initial cell clone, MCB or WCB) should be the same as for the MCB, unless justified.

A file containing the original signed documents or procedures.

A culture of a microorganism distributed from a single bulk into containers and processed together in a single operation in such a manner as to ensure uniformity and stability and to prevent contamination. A master seed lot in liquid form is usually stored at or below -70°C. A freeze-dried master seed lot is stored at a temperature known to ensure stability.

Master Service Agreement specifying generic terms such as payment terms, product warranties, intellectual property ownership, and dispute resolution.

Statement of work between sponsor and a contract vendor describing the specific services requested by sponsor. The agreement includes the project scope, schedule, the functional requirements, and specifications of any computer software, various projet activities, and tasks to be performed by the parties, payment terms, deliverables, and roles and responsibilities of the parties.

(ICH Q7) A general term used to denote raw materials (starting materials, reagents, solvents), process aids, intermediates, APIs and packaging and labeling materials.

(ISO/DIS 10993-1) Any synthetic or natural polymer, metal, alloy, ceramic, or other nonviable substance, including tissue rendered nonviable, used as a medical device, or any part thereof.

The method to incorporate suitable measures into design procedures and operational practices for the containment of materials that can harm personnel and the workplace environment, and minimize potential for cross contamination and housekeeping concerns in the fine chemical, bulk pharmaceutical and pharmaceutical industries. Solids and/or liquids are normally most hazardous in the form of powders and have been divided into the following three categories:1.Biologically Hazardous additives are compounds that when contacting a living cell will alter, endanger, or damage the cell in some shape or form. These should be treated as requiring total containment.2.Chemically Hazardous additives are compounds that when coming into contact with an oxidant, will cause harm to its surroundings due to reaction and/or oxidation. These products usually require containment and/or blanketing with an inert gas.3.General Intermediates are compounds that are neither biologically nor chemically hazardous additives but they will cause a housekeeping problem. They usually require dusting prevention.

Document produced by the manufacturer that contains the chemical and physical properties of a substance that are pertinent to safe handling and storage.

Document describing the chemical and physical properties of a substance as related to its safe handling and storage. The substance manufacturer originates it.

A commercial designation for a given chemistry range.

(ICH Q1A (R2)) The design of a stability schedule such that a selected subset of the total number of possible samples for all factor combinations is tested at a specified time point. At a subsequent time point, another subset of samples for all factor combinations is tested. The design assumes that the stability of each subset of samples tested represents the stability of all samples at a given time point. The differences in the samples for the same drug product should be identified as, for example, covering different batches, different strengths, different sizes of the same container closure system, and, possibly in some cases, different container closure systems.

Master Air Way Bill

The maximum ratio of chromium to iron and the depth at which it occurs are the most direct measures of the chromium enrichment in a material oxide layer. Typical ratios are about 1:5 or greater for well-electropolished 316L stainless steel. The depth at which the maximum Cr/Fe ratio is found varies but is usually about one-half the oxide thickness.

In stainless steel the chromium enrichment layer comprises all depths at which the chromium concentration is greater than the iron concentration. For well electropolished 316L stainless steel, the maximum depth of this layer is typically 20 to 25 angstroms (Å).

The pressure at which the system is capable of operating for a sustained period of time.

The maximum temperature at which the system may operate for a sustained period. The maximum working temperature should relate to the maximum working pressure and the fluids involved.

The volume at which a vessel is designed and routinely operated. In a vertical vessel, this location is generally located at the top head weld seam or slightly below; such as to allow spray ball assemblies not to be in contact with the product.

Megabit

Megabyte