Glossary

A prescribed number of activities designed to take equipment and systems from static, substantially complete state to an operable state.

A well planned, documented, and managed engineering approach to the start-up and turnover of facilities, systems, and equipment to the end-user, that results in a safe and functional environment that meets established design requirements and stakeholder expectations.

Planned and documented series of inspections, adjustments, and tests carried out systematically to set the installation into correct technical operation as specified.

A well planned, documented, and managed engineering approach to the start-up and turnover of facilities, systems, and equipment to the end-user that results in a safe and functional environment that meets established design requirements and stakeholder expectations.

(IEEE) The process of providing to the appropriate components, the information necessary for the designed communication between components.

Commissioning is a quality oriented process for verifying and documenting that the performance of facilities, systems and assemblies meets defined objectives and criteria.

The documented process of verifying that equipment and systems are installed according to specifications, placing the equipment and systems into active service, and verifying their proper operation.

A plan that defines the facilities, systems, and equipment that will be commissioned based on agreed system boundaries.

A plan that defines the facilities, systems, and equipment that will be commissioned based on agreed system boundaries. It also defines how they will be commissioned and what the responsibilities for the associated staff personnel are.

Team usually consisting of representatives from the major stakeholder and/or decision-making groups. The CST is responsible for managing changes to the Commissioning Plan and directing the detailed commissioning activities.

(ICH Q1A (R2)) Production batches of a drug substance or drug product for which the stability studies are initiated or completed post approval through a commitment made in the registration application.

Also known as 45 CFR 46. Outlines requirements of federally supported research with regards to human subjects protections and places the responsibility of these protections on institutions, their Institutional Review Boards (IRBs), and investigators. Among other requirements, the Common Rule mandates that all researchers obtain informed consent from human subjects to participate in research, unless the IRB has approved a waiver of the requirement for informed consent. Partners policy and assurances to the government require all research (not just federally supported studies) to adhere to the Common Rule.

Defines key project stakeholders and the type and frequency of communication.

A compact disk used for the permanent storage of text, graphic or sound information. Digital data is represented very compactly by tiny holes that can be read by lasers attached to high resolution sensors. Capable of storing up to 680 MB of data, equivalent to 250,000 pages of text, or 20,000 medium resolution images. This storage media is often used for archival purposes. Synonyms: Optical Disk, Write-Once Read-Many Times Disk.

Refers to the regulated entity (such as company, partnership, corporation, or association). It is synonymous with the term “firm”, as used by the FDA, and “User Company” as used in GAMP 4.

Company identified by name and Pictogram.

(ICH Q5E) A study performed to provide nonclinical or clinical data that allows extrapolation of the existing data from the drug product produced by the current process to the drug product from the changed process.

(ICH Q5E) The activities, including study design, conduct of studies, and evaluation of data, that are designed to investigate whether the products are comparable.

(ICH Q5E) A conclusion that products have highly similar quality attributes before and after manufacturing process changes and that no adverse impact on the safety or efficacy, including immunogenicity, of the drug product occurred. This conclusion can be based on an analysis of product quality attributes. In some cases, nonclinical or clinical data might contribute to the conclusion.

The comparison of map locations of genes between species. The results of these comparisons indicate substantial conservation of blocks of genes and even large segments of chromosomes between species. Great use can be made of this conservation of map position. For example, in the case of mammals, it means that if a gene has been mapped in one or both of the intensely-mapped species (humans and mice), then the likely location of that gene in other mammals can be predicted with considerable confidence. Conversely, if a mapped anonymous DNA marker has an effect on a quantitative trait (this being indicative of the marker being linked to a quantitative trait locus (QTL)) in, say, cattle, then knowledge of the comparative map between cattle and humans can identify genes in the homologous region of the human genome that could correspond to the QTL. Such genes are called comparative positional candidate genes.

The study of human genetics by comparisons with model organisms such as mice, the fruit fly, and the bacterium E. coli.

A commercially available drug product to be used in a clinical trial in direct comparison with a sponsor’s proprietary Investigational Medicinal Product.

(IEEE) Software tool that compares two computer programs, files, or sets of data to identify commonalities or differences. Typical objects of comparison are similar versions of source code, object code, data base files, or test results.

An investigational or marketed product ( i.e., active control) or placebo used as a reference in a clinical trial. The comparator is considered an IMP because during the clinical trial, one gains information concerning the effectiveness of the comparator to its self or relative to another medical product.

One of the mechanisms by which FDA makes investigational new drugs and devices that are not yet approved for marketing available to very ill patients who have no other treatment options.