Glossary

The solid surface of which a cell moves or on which cells grow.

In metals, a rise in the carbon signal at depths from 15 to 20 angstroms (Å). This indicates that organic material is buried in cracks, crevices, pits, or smeared material. Subsurface carbon is most commonly found in materials having rough morphology generally associated with machining processes.

A procedure used to fractionate mRNAs or DNA fragments on the basis of size.

A strategy for making cancer cells more vulnerable to chemotherapy. One approach has been to link parts of genes expressed in cancer cells to other genes for enzymes not found in mammals that can convert a harmless substance into one that is toxic to the tumor.

(EMEA – CHMP) Assessment of the container closure system in regard to protection, safety, compatibility and performance (function).

An architectural designation for a collection of adjacent and associated rooms that as a unit serve to house the equipment (one or several unit operations) associated with a "train". A suite has one entrance and one exit, and is typically established to satisfy a need associated with Primary Segregation. While a product "Train" may require several "Suites", conversely, several trains may be located in one suite. Samples of "Suites" would be Media or Buffer Preparation, Fermentation/Recovery or Purification.

Any compound of sulfur and another element, usually made by direct reaction of the elements.

Scale-Up and Post-Approval Change

Guidance documents developed by the Center for Drug Evaluation and Research (CDER) as a means of maintaining product safety, efficacy, and quality, while providing substantial regulatory relief and flexibility to manufacturers. The SUPAC guidance documents make recommendations to drug product sponsors who intend the post-approval changes to the product in: the components or composition, the site of manufacture, and/or the manufacturing process and equipment.The concept of SUPAC is based on 21 CFR 314.70(a). There are six SUPAC guidance documents currently in existence or development, and FDA has asked ISPE to produce addenda for these as well.1.Immediate Release (SUPAC-IR) Solid Oral Dosage Forms2.Modified Release (SUPAC-MR) Solid Oral Dosage Forms3.Nonsterile Semi-Solid (SUPAC-SS) Dosage Forms4.Transdermal Products (SUPAC-TDS) – in development5.Bulk Additives (BACPAC) – in development6.Aqueous Solutions (PAC-SAS) – in development

Scale-Up and Post-Approval Change – Modified Release

Scale-Up and Post-Approval Change – Immediate Release

A subgroup of austenitic stainless steels having elevated levels of nickel, chromium, and molybdenum compared with standard austenitic stainless steels, e.g., UNS S31603 (316L), and that may have other additions, e.g., nitrogen and/or copper, to increase strength and resistance to pitting corrosion and stress corrosion cracking in the presence of chlorides.

Those duplex stainless steel whose chemical composition is designed to result in a pitting resistance equivalent number (PREN) of at least 40.

Jargon for the bacterial strain of Pseudomonas developed by Chakrabarty, who combined hydrocarbon-degrading genes carried on different plasmids into one organism. Although this genetically engineered micro-organism is neither “super” nor a “bug”, it represents a landmark example because it showed how genetically modified microbial strains could be used in a novel way and because it was the basis for the precedent-setting legal decision that declared that genetically engineered organisms were patentable.

Supercritical Fluid Extraction (SFE) refers to a process in which a Supercritical Fluid (SF) is used as a solvent. At critical temperatures and pressures, SFs possess the properties of both the liquid and gas, with density values similar to those of liquids and flow properties similar to those of gases, and are thus labeled as fluids. The most widely used SF gas is carbon dioxide (CO2).

(EN 285) Steam whose temperature, at any given pressure, is higher than the indicated by the vaporization curve of water.

The material floating on the surface of a liquid mixture (often the liquid component that has the lowest density).

The overlying fluid layer that remains after precipitation of a solid component through centrifugation.

The off-label uses of a drug may become additional on-label uses if the company submits a Supplemental New Drug Application and the FDA approves the application. SNDAs may take years to process and can be expensive. When a drug is off-patent or if the off-label use is for only a small population, there is little incentive (except that it is easier to advertise on-label uses) for a firm to obtain an SNDA.

(ISO) Organization or person that provides a product.

Organization engaged to satisfy the specified requirements of a cleanroom or clean zone.

An organization or individual internal or external to the user associated with the supply and/or support of products or services at any phase throughout a systems life cycle.

(ISO) Any organization or individual contracted directly by the customer to supply a produc or service.

Building or area owned by the end manufacturer or supplier of the equipment to be tested.

The ongoing process of evaluating a supplier against established quality standards, managing noted deficiencies, and working with supplier to improve the quality of its products or services and documentation.