Glossary

A suspension culture continuously supplied with nutrients by the inflow of fresh medium. The culture volume is normally constant.

The technique of continuous diafiltration (also known as constant volume diafiltration) involves washing out the original buffer salts (or other low molecular weight species) in the retentate (sample) by adding water or a new buffer to the Retentate at the same rate as filtrate is being generated.

A process in which sterile medium is added without interruption to the fermentation system with a balancing withdrawal (or “harvesting”) of broth for product extraction. The length of fermentation can be measured in weeks or months. Commercial applications of continuous fermentation are limited in number, with ethanol production by yeast the most important example.

Two or more pieces of process equipment connected together for the purpose of the progressive processing and transfer of ingredients to an intermediate or final state. The intent of using this term is to distinguish from individual, discrete pieces of process equipment viewed or analyzed in a “stand-alone” fashion. NOTE: the phrase “continuous process train” is also not necessarily meant to mean “continuous processing”. For this Guide (Assessing the Particulate Containment Performance of Pharmaceutical Equipment), “continuous refers to the connectivity or adjacency of process steps, not as a distinction from the “batch” operations.

An agreement that a specific research activity will be performed at the request, and under the direction, of the agency providing the funds. This agency is called the sponsor. Research performed under contract is more closely controlled by the agency (FDA) than research performed under a grant.

Third party carrying out the contract on behalf of the Contract Giver.

Person(s) responsible for awarding calibration contracts to third party contractors.

A company holding an agreement requiring the performance of some aspect of API manufacturing.

(ICH Q7) A manufacturer performing some aspect of manufacturing on behalf of the original manufacturer.

Process by which the Owner and Supplier agree to the terms of a formal contract.

A company with whom a drug or device manufacturer or sponsor contracts to perform clinical trial related activities. CROs may contract to develop protocols, recruit patients, collect and analyze data, and prepare documents to submit marketing applications to FDA.

Disadvantageous, perhaps dangerous; a treatment that should not be used in certain individuals or conditions due to risks (e.g., a drug may be contraindicated for pregnant women and persons with high blood pressure).

Subject(s) used for comparison who are not given a treatment under study or who do not have a given condition, background, or risk factor that is the object of study. Control conditions may be concurrent (occurring more or less simultaneously with the condition under study) or historical (preceding the condition under study). When the present condition of subjects is compared with their own condition on a prior regimen or treatment, the study is considered historically controlled.

A building or portion of a building within which the exempted amounts of hazardous materials may be stored, dispensed, handled, or used.

(ANSI) A bus carrying the signals that regulate system operations.

A quantity of cells set aside, at the time of virus inoculation, as uninfected cell cultures. The uninfected cells are incubated under similar conditions to those used for the production cell cultures.

(ISO) In programming languages, an abstraction of all possible paths that an execution sequence may take through a program.

(IEEE) A software V&V task to ensure that the proposed control flow is free of problems, such as design or code elements that are unreachable or incorrect.

(IEEE) A diagram that depicts the set of all possible sequences in which operations may be performed during the execution of a system or program. Types include box diagram, flowchart, input-process-output chart, state diagram.

The group of subjects in a controlled study that receives no treatment, receives a standard treatment, or receives a placebo.

A sensor (e.g. temperature, pressure, pH, flow, and all other sensors delivering to systems and/or operators a given physico-chemical measurement) All measurement resulting from composite parameters belong to this category as well.

A collection of sensors, actuators, other control modules, and associated process equipment that, from the point of view of control, is operated as a single entity.

Those operating variables that can be assigned values and are used as control levels.