Deterministic Leak Test Method
A method in which the leakage event being detected or measured is based on phenomena that follow a predictable chain of events. In addition, the measure of leak detection is based on physicochemical technologies that are readily controlled and monitored, yielding objective quantitative data. (TR86)
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Destructive
A method in which a sample cannot be subsequently utilized in any other analytical method or processed to a final product. (TR86)
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Data Lake
A storage repository that holds, in a structured way, a vast amount of raw data, including metadata, in its native format until it is needed. (TR84)
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Data Integrity Controls
Controls put in place to either minimize the potential for a data integrity issue to occur or, if an issue does occur, the controls applied to increase the probability of detection.(TR84)
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Data Vulnerability
An indicator of data’s level of exposure to data integrity failures due to intrinsic weaknesses in manufacturing processes, data-capture technology, and human factors or a combination thereof.(TR84)
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Data Process Flow Map
A flow map that uses a baseline process flow map and overlays the data flow. (TR84)
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Design Specification
Controlled documentation that clearly and explicitly defines the manufacturing system details, codes, and standards to be followed during fabrication and construction to meet associated requirements. (TR54-5)
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Design Reviews
Planned and systematic reviews of specifications, design, and design development and continuous improvement changes performed as appropriate throughout the lifecycle of the manufacturing system. Design reviews evaluate deliverables against standards and requirements, identify problems, and propose required corrective actions. (TR54-5)
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Difficult-to-inspect Parenterals (DIP)
When the nature of the product or package limits the ability to perform a thorough inspection for particles. (TR79)
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Dynamic (in operation)
BFS machine line fully operational and filling, with the number of allowed operating personnel present as during normal running conditions. (TR77)
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Defect (ISO def.)
The nonfulfillment of intended usage requirements. The departure or absence of one or more quality characteristics from intended usage requirements. (TR76)
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Defect (ANSI def.)
A departure of a quality characteristic from its intended level or state that occurs with a severity sufficient to cause an associated product or service not to satisfy its intended normal or foreseeable usage requirements. (TR76)
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Dynamic Record Format (MHRA)
An electronic record which the user reviewer can interact with.(TR80)
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Data (MHRA)
Facts, figures and statistics collected together for reference or analysis. All original records and true copies of original records, including source data and metadata and all subsequent transformations and reports of these data, that are generated or recorded at the time of the GXP activity and allow full and complete reconstruction and evaluation of the GXP activity.(TR80)
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Dynamic Record Format (WHO)
Records, such as electronic records, that allow for an interactive relationship between the user and the record content.(TR80)
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Data (WHO)
Data means all original records and true copies of original records, including source data and metadata and all subsequent transformations and reports of this data, which are generated or recorded at the time of the GXP activity and allow full and complete reconstruction and evaluation of the GXP activity. Data should be accurately recorded by permanent means at the time of the activity. Data may be contained in paper records (such as worksheets and logbooks), electronic records and audit trails, photographs, microfilm or microfiche, audio- or video-files or any other media whereby information related to GXP activities is recorded.(TR80)
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Dynamic Record Format (FDA)
The record format allows interaction between the user and the record content.(TR80)
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Data Integrity (FDA)
Refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).(TR80) (TR84)
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Data Integrity (WHO)
The degree to which data are complete, consistent, accurate, trustworthy and reliable and that these characteristics of the data are maintained throughout the data life cycle. The data should be collected and maintained in a secure manner, such that they are attributable, legible, contemporaneously recorded, original or a true copy and accurate. Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices.(TR80) (TR84)
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Data Lifecycle (WHO)
All phases of the process by which data is created, processed, reviewed, analyzed and reported, transferred, stored and retrieved and monitored until retirement or disposal. There should be a planned approach to assessing, monitoring and managing the data and the risks to those data in a manner commensurate with potential impact on patient safety, product quality and/or the reliability of the decisions made throughout all phases of the data life cycle. (TR80)(TR84)
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Data Integrity (MHRA)
The degree to which data are complete, consistent, accurate, trustworthy, reliable and that these characteristics of the data are maintained throughout the data life cycle. The data should be collected and maintained in a secure manner, so that they are attributable, legible, contemporaneously recorded, original (or a true copy) and accurate. Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices.(TR80) (TR84)
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Data Lifecycle (MHRA)
All phases in the life of the data (including raw data) from initial generation and recording through processing (including transformation or migration), use, data retention, archive/retrieval and destruction.(TR80) (TR84)
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Disinfectant
A chemical or physical agent that reduces, destroys, or eliminates vegetative forms of harmful microorganisms but not spores. (TR70)
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Dwell Time
The period that items are subjected to a given processing condition. [Synonym: Residence Time] (TR3)
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D-value (D10 -Value)
The time in minutes required for a one-logarithm, or 90%, reduction of the population of microorganisms used as a biological indicator under specified lethal conditions. (TR51)
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Distribution Thermocouple
Device placed in the interior of the controlled environment space (CES) to measure air temperature but is not placed in the product (see penetration thermocouple). (TR64)
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D-Value
The time in minutes required for a one-logarithm, or 90%, reduction of the population of microorganisms used as a biological indicator under specified lethal conditions. For dry-heat sterilization, the D-value should always be specified with a reference temperature, DT. For example, a biological indicator (BI) challenge system with a D 160°C=1.9 minutes, requires 1.9 minutes at 160°C to reduce the population by one logarithm. (TR3) The time in minutes at a specific temperature required to reduce the population of a specific microorganism by 90% [or one (1) log] in defined conditions [e.g., method of sterilization (dry heat versus steam), solute, or carrier]. (TR13)
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Drug Product (DP)
A pharmaceutical product type that contains a drug substance, generally, in association with excipients. [Synonym: Dosage Form; Finished Product] (TR57)(TR14)(TR42)
A finished dosage form (e.g., tablet, capsule, or solution) that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients.(TR38) (TR67) (TR88)
The dosage form in the final immediate packaging intended for marketing.(TR60)(TR82)
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Downstream
Refers to the demand side of the supply chain. Downstream consists of one or more companies or individuals who participate in the flow of goods and services moving from the manufacturer to the final user or consumer. This is the opposite of upstream. (TR46)
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Drug Shortage Prevention & Response Plan
A document that provides a structured action plan to proactively prevent drug shortages and also respond to a shortage in the event that one occurs. (TR68)
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Dryness Value
A dimensionless test quantity developed to approximate the dryness fraction. (TR01)
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Documentation
See Development Reports , Process Characterization Report , Process Validation Protocol, or Process Validation Report (TR14) (TR42)
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Distribution Temperature
The temperature range, supported by stability studies, within which a medicinal product can be transported for a short duration of time without adverse effect on quality parameters. (TR39)
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Distribution
Transport of a medicinal product from a drug manufacturer’s warehouse/storage facility to distribution centers, commercial customers, or clinical facilities. Subsequent distribution may also occur. (TR39) Movement of product within a designated supply chain, including activities that range from preparation for shipment to receipt of the product at the final destination.(TR58)
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Dynamic Monitoring
Monitoring of an environment during normal operations, that is, when the usual equipment is operating and personnel are present, and the process or simulated process is ongoing. Per the EU and ISO documents this is synonymous with operational condition (including the equipment operating and personnel present). (TR13)
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Dynamic Light Scattering (DLS)
A technique used to measure the size and size distribution of particles. Particles suspended in a solution will cause scattering of light and the extent of the scattering is related to the size and shape of the particles. (TR47)
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Dryness Fraction
An absolute measure of the actual latent heat of a sample of steam relative to the theoretical latent heat of saturated steam. (TR01) (TR48)
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Distribution Testing
Qualification of packaging components for physical distribution integrity like shock, vibration, and drop tests. (TR58)
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Drug Substance (DS)
The active ingredient that is subsequently formulated with excipients to produce the drug product. It can be composed of the desired product, product-related substances, and product- and process-related impurities. It may also contain excipients, including buffers and other components. [Synonyms: bulk drug substance, bulk material, active pharmaceutical ingredient (API)] (TR14) (TR57) (TR74) (TR60)
Active pharmaceutical ingredient in a drug product that is responsible for that product’s therapeutic activity.(TR67) (TR82) (TR88)
See Active Pharmaceutical Ingredient (API). (TR56)
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Disinfection
The destruction of pathogenic and other kinds of microorganisms by thermal or chemical means. (TR51) (TR70) Process of eliminating nearly all recognized pathogenic microorganisms but not necessarily all microbial forms (e.g., bacterial spores) on inanimate objects. (TR69) The chemical or physical inactivation of a bioburden on inanimate surfaces. Typically this requires a minimum three-log (3-log) reduction of vegetative microorganisms and two-log (2-log) reduction for bacterial spore be achieved in validation. (TR13)
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Downstream Side (of Filter)
The effluent side of the process step (filter). (TR45) The filtrate or outlet side of the filter. (TR26)
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Drug Development
A general term used to define the entire process of bringing a new drug to the Market. It includes drug discovery, process and product development, pre-clinical research (microorganisms/cell culture/animals) and Clinical trials (on humans). (TR56)
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Dry Equipment
No visible water in the equipment or line when viewed under appropriate lighting conditions. (TR29) No visible water pool evident in the equipment or line when viewed under appropriate lighting conditions. (TR49)
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Drug Shortage Risk Register
A single source of information on risks that can result in drug shortages, associated risk levels, risk control actions with owners, status, due dates and residual risk after appropriate risk control actions have been taken. (TR68)
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DT Value
The time in minutes required for a onelogarithm, or 90%, reduction of the population of microorganisms used as a biological indicator under specified lethal conditions. For steam sterilization, the D-value should always be specified with a reference temperature, DT . For example, a BI system with a D121°C = 1.4 minutes requires 1.4 minutes at 121°C to reduce the population by one logarithm.(TR1) (TR61)
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Date of Manufacture
For small molecules, the date of manufacture of a drug product is considered to be the initial date that an active ingredient has been added during manufacturing. For biologics the date of manufacture can be determined in multiple ways and should be consistent with internal quality systems and the product license application. (TR53)
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Deionized Water
Water treated by passing through both cation- and anion-exchange resin beds, or a mixed-resin bed to remove both positive and negative ions. (TR45)
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Design Qualification (DQ)
Documented verification that the proposed design of the systems is suitable for the intended purpose. Also establishing confidence that ancillary component systems are capable of consistently operating within established limits and tolerances. (TR39) (TR48) (TR64) (TR 72)
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Defect
(1) A departure of a quality characteristic from its intended level or state that occurs with a severity sufficient to cause an associated product or service not to satisfy its intended normal or foreseeable usage requirements. (TR51) (2) The nonfulfillment of intended usage requirements. The departure or absence of one or more quality characteristics from intended usage requirements. (TR43)
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Depth Filter
A matrix of randomly distributed fibers creating a tortuous path with pores of undefined size and shape. A filter that removes particles by a combination of adsorption and size exclusion within its porous matrix rather than on its frontal surface. (TR45)
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