Error, Laboratory
A self-evident documented mistake that will bring the validity of a laboratory test into question. (TR88)
Source:
Error, Manufacturing
A self-evident documented mistake that will bring the manufacturing process into question. (TR88)
Source:
Early Phase
Generally used to indicate Phase 1 and A clinical studies.(TR 56)
Source:
Emulsions
A dispersed colloidal system consisting of two immiscible liquid phases generally stabilized with one or more suitable agents. Injectable emulsions are sterile liquid dosage forms of drug substances dissolved or dispersed in a suitable emulsion medium. Injectable emulsions are for parenteral administration of poorly water-soluble drugs. (TR79)
Source:
Extrinsic Particles
Those particles that are not part of the formulation, package, or assembly process but rather are foreign and unexpected. Materials such as rubber, metal, and plastic are defined as extrinsic in cases where the specific material identified is not a product-contact material. (TR78)
Foreign material that comes from outside the primary process. Often these are from the manufacturing environment or incomplete cleaning of components. They are uncontrolled. (TR85)
Source:
Exposure Phase
The phase of the sterilization cycle in which the appropriate parameters are maintained within defined ranges for the time (exposure time or dwell period) and temperature determined to be necessary to achieve the desired lethality. (TR1) (TR3) (TR30) (TR48) (TR61)
Source:
Extractable
A chemical component that is removed from a material by application of an artificial or exaggerated force (e.g., solvent, temperature, time). The term extractable is often erroneously used to describe a leachable. (TR14) (TR15) (TR26) (TR41) (TR45) Chemical substances that can be extracted from components of material process fluid contact surfaces by exertion of an exaggerated force (e.g., organic solvent, extreme elevated temperature, ionic strength, pH, contact time, etc.) Extractables may represent most but not all of the potential leachables that may be seen in process fluids. (TR66) Extractables are organic and inorganic chemical entities that can be released from a pharmaceutical packaging/delivery system, packaging component, or packaging material of construction under laboratory conditions. (TR54-4) Organic or inorganic chemical entity that is forced out of container closure system materials and components under laboratory experimental conditions. (TR73)
Source:
Extraction Control
A known test article processed with a nucleic acid extraction procedure in order to ensure the proper extraction of nucleic acid. (TR50)
Source:
Excursion
A temperature or humidity deviation from conditions such as those specified by product labeling or shipping specifications. (TR53) Measurement that exceeds an alert, concern, or action level/limit by either a discreet value or an increasing/decreasing trend. (TR69)
Source:
Exclusivity
The capacity of an assay not to detect microorganisms closely related to a target microorganism. (TR33)
Source:
Extended Producer Responsibility (EPR)
Refers to a legislative requirement that packaging manufacturers “take back” their packaging, or otherwise ensure (through a tax) that it is collected and properly disposed of. (TR46)
Source:
Exotoxin
Lipopolysaccharides from the cell walls of bacteria, the most potent of which derive from Gram-negative organisms. When injected, they are known to cause a febrile, or fever-producing reaction that can cause severe patient reactions, and on occasion, can be fatal. (TR26) (TR44)
Pyrogenic lipopolysaccharide component of Gram-negative bacterial cell walls.(TR69)
The major constituent of the outer membrane of Gram-negative bacteria is composed of lipid A, the core polysaccharide, and the O-antigen polysaccharide; endotoxin is also known as lipopolysaccharide (LPS).(TR82)
Source:
Excipient
A component of a drug formulation that has no active pharmacologic function. Excipients are commonly used in drug formulations as modulators of pH or osmolality for parenteral administration and as stabilizers for APIs. (TR54-4)
An ingredient added intentionally to the drug substance that should not have pharmacological properties in the quantity used. (TR57)
Inactive pharmaceutical ingredients in a product formulation that are responsible for the product’s manufacturability and physicochemical attributes. (TR67) (TR88)
Source:
Extemporaneous Preparation (EP)
A type of compounding whereby a drug or combination of drugs and/or excipients is prepared under the supervision of a pharmacist to create a customized medication dosage form in accordance with a clinical protocol. (TR63)
Source:
Extracellular Polymeric Substance (EPS)
Product of microbial growth, particularly in biofilms, composed of polysaccharides, lipids, proteins, and nucleic acids; produced by bacteria and fungi; is an important mediator of microbial attachment to surfaces and biofilm formation. (TR69)
Source:
Extraction Recovery
The efficiency of extraction of target analyte from a test matrix. It is usually measured as ratio (percentage) of analyte amount extracted from the matrix to that originally present in the matrix before extraction. (TR50)
Source:
Extrusion Force (Propagation Force, Glide Force, Syringeability)
Filled syringe delivery force (that does not include break-loose force) quantified as the highest non-break-loose force to complete the injection stroke. (TR73)
Source:
Equivalence Margin
The largest difference between the results from two methods that is considered as being scientifically and statistically acceptable. (TR57)
Source:
Equivalence Test
Test of conformance to interval-based target acceptance criteria; differs from most common statistical tests in the nature of the statistical hypothesis. In equivalence testing, the alternative hypothesis is that the difference is sufficiently small that no important difference exists. A common statistical procedure used for equivalence testing is the two one-sided T-test. (TR57-2)
Source:
Equivalence
See Comparability. (TR38) A comparison with the primary objective of showing that the results from two methods differ by an amount which has negligible impact on fitness for use. This is usually demonstrated by showing that the true difference is likely to lie between a lower and an upper equivalence margin of acceptance differences. (TR57)
Source:
Event Tree Analysis (ETA)
A systematic technique that employs forward logic to construct a graphical representation of consequences from an initiating event. (TR54)
Source:
Error
Deviation from expected value. Error may be random or systematic. (TR57)
Source:
Equivalence/Comparative Testing
A measure of how similar the test results are when compared with the existing method. (TR33)
Source:
Evaporator
Component that transfers heat out of or into the CES (to control the area temperature). (TR64)
Source:
Equipment Train
The sequence of equipment through which a product is produced or processed. (TR29) (TR49)
Source:
Enzyme-Linked Immunosorbent Assay, or ELISA
A biochemical technique used to detect or measure the presence of an antibody or an antigen in a sample. (TR41) (TR47)
Source:
Enabler
A tool or process which provides the means to achieve an objective (ICH Q10). (TR54)
Source:
Electronic Record
A record used for GMP purposes or for regulatory submission that is stored electronically for the purposes of reproduction, retrieval or archival. (TR48)
Source:
Elution
Desorption of a drug substance from a chromatographic column. (TR14)
Source:
Elastomer
Thermoplastic material formulation (that may or may not contain rubber/natural latex) derived from elastic polymer; often used interchangeably with the term “rubber.” (TR73)
Source:
Environmental Flora (isolates)
Microorganisms associated with a processing environment. (TR22)
Source:
Early Phase (Generally used to indicate the following clinical study activities)--Phase 2 Trials
Once the initial safety of the study drug has been confirmed in Phase 1 trials, Phase 2 trials are performed on larger groups (20-300) are designed to assess efficacy, as well as to continue safety assessments in a large group of volunteers and patients. Phase 2a is specifically designed to assess dosing requirements (how much drug should be given). Phase 2b trials are specifically designed to study efficacy (how well the drug works at the prescribed dose(s). (TR56)
Source:
Economically Motivated Adulteration
The fraudulent, intentional substitution or addition of a substance in a product for the purpose of increasing the apparent value of the product or reducing the cost of its production (i.e., for economic gain). (TR54-3)
Source:
Effluent
The liquid flowing out of a column. (TR14) Fluid that flows out of a process step. (TR26)
Source:
Endotoxin
Lipopolysaccharides from the cell walls of bacteria, the most potent of which derive from Gram-negative organisms. When injected, they are known to cause a febrile, or fever-producing reaction that can cause severe patient reactions, and on occasion, can be fatal. (TR26) (TR44) Pyrogenic lipopolysaccharide component of Gram-negative bacterial cell walls. (TR69)
Source:
Endotoxin Indicator (EI) for Depyrogenation
An article challenged with a vial of endotoxin (or a carrier spiked with endotoxin) designed for use in depyrogenation studies. The endotoxin (a purified lipopolysaccaride) is validated for use in or on an endotoxin indicator. The carrier is made from a material appropriate for the intended depyrogenation processes to which it will be subjected. The endotoxin on a carrier is added at a concentration sufficient to allow recovery of a minimum of 1000 USP endotoxin units/carrier. The endotoxin indicator would allow for accurate indication of at least a 3-log reduction in USP endotoxin units during depyrogenation process challenges. (TR3)
Source:
End-Of-Production Cells (EOPC)
Cells cultured (under conditions comparable to those used in production) from the MCB or WCB to a passage level or population doubling level comparable to or beyond the highest level reached in production. Note: The ICH term is: “Cells at Limit of invitro Cell Age Used for Production”.
Note: The term as defined in ICH Guidance Q5 D is “Cells at Limit of in vitro Cell Age Used for Production”; also abbreviated as EPC. (TR56)
Source:
Environmental Monitoring Program
Defined documented program which describes the routine particulate and microbiological monitoring of processing and manufacturing areas, and includes a corrective action plan when action levels are exceeded. It includes assessment of environmental air, surfaces and personnel. (TR22) (TR28) (TR62)
Source:
Equilibration
Column washing with a solution or buffer(s) in preparation for the column load. (TR14)
Source:
Endogenous Virus-Like Particles – (e.g., Type C endogenous retroviruses)
Virus-like entity whose genetic material is stably integrated into the germ line of an organism or cell line. Cell lines (notably CHO) may constitutively produce virus-like particles, which are typically noninfectious but still of safety concern. Model retroviruses are generally used as surrogates to measure virus-like particle clearance. (TR41)
Source:
Emissivity (?)
The emissivity of the surface of a material is its effectiveness in emitting energy as thermal radiation. This is measured between 0 (zero) and 1 (one); 0 having the ability to reflect all energy, and 1 allowing all energy to pass through it. Glass, for example, has emissivity of 0.91 (smooth, uncoated); aluminium foil has emissivity of 0.03. (TR72)
Source:
Early Phase (Generally used to indicate the following clinical study activities) --Microdosing Studies
Studies designed to speed up the development of promising drugs by establishing very early on whether the drug or agent behaves in human subjects as was expected from preclinical studies. May include the administration of single sub therapeutic doses of the study drug to a small number of subjects (10 to 15) to gather preliminary data on the agent’s pharmacokinetics (how the body processes the drug) and pharmacodynamics (how the drug works in the body). A microdosing study gives no data on safety or efficacy, being by definition a dose too low to cause any therapeutic effect. (TR56)
Source:
Endospore
A type of spore formed intracellularly by some bacterial genera. (TR51)
Source:
Effective Filtration Area
The total surface area of the filter available to the process fluid. (TR26)
Source:
Eluate
Solution (effluent) that flows out of the chromatographic column containing the drug substance. [Synonym: collected product fractions] (TR14)
Source:
Electronic Nose
An array of electronic sensors designed to selectively identify chemicals responsible for odors. The zNose™ system is one example that is commercially available and consists of a vapor pre-concentrator, a direct-heated high-speed chromatography column, a solid-state sensor and a programmable gate array microprocessor system. (TR55)
Source:
Endpoint PCR
A classical PCR method based on repeated cycling of the reaction mixture between two or three temperatures (denaturing, annealing, and extension) with detection of the amplified product after reaction completion (e.g., by agarose gel electrophoresis). (TR50)
Source:
Early Phase (Generally used to indicate the following clinical study activities)
Generally used to indicate the following clinical study activities: Microdosing Studies, Phase 1 Trials, Phase 2 Trials, and Phase 3 Trials. See any of the following studies for more information. (TR56)
Source:
Eductor
A device that produces vacuum by means of the Venturi effect. [Synonym: Aspirator, ejector pump] (TR48)
Source:
Environmental Monitoring (EM)
Describes the processes and activities that need to take place to characterize and monitor the quality of the environment. (TR70)
Monitoring for nonviable particulates and/or microorganisms where the result meets or exceeds the alert and/or action level or limit. (TR88)
Source:
