PDA Technical Glossary
PDA Technical Reports are highly valued membership benefits because they offer expert guidance and opinions on important scientific and regulatory topics and are used as essential references by industry and regulatory authorities around the world. These reports include terms which explain the material and enhance the reader’s understanding.
The database presented here includes the glossary terms from all current technical reports. The database is searchable by keyword, topic, or by technical report. Each definition provided includes a link to the source technical report within the PDA Technical Report Portal.
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- TR 3: Validation: Dry Heat (3)
- TR 48: Moist Heat Sterilizer Systems (2)
- TR 54: QRM:Manufacturing Operations (1)
- TR 54-2: QRM: Packaging Labeling (1)
- TR 56: Phase Appropriate cGMP Application (1)
- TR 57-2: Analytical Method Development (1)
- TR 60: Process Validation (1)
- TR 70: Cleaning/Disinfection Programs (1)
- TR 1: Validation: Moist Heat (1)
- TR 14: Validation: Protein Purification Chromatography (1)
- TR 15: Validation: TFF in Biopharmaceuticals (1)
- TR 26: Sterilizing Filtration of Liquids (1)
- TR 30: Parametric Release (1)
- TR 60-2: Process Validation: A Lifecycle Approach, Annex 1: Oral Solid Dosage/Semisolid Dosage Forms (1)
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Target Criteria
Numerical limits, ranges, or other suitable measures of target performance levels of an analytical method that indicate suitable performance for intended use. For a method entering qualification, this is a target performance criterion that, when assessed, indicates that the method is qualified for its intended purpose. (TR57-2)
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Target Product Profile (TPP)
A format for a summary of a drug development program described in terms of labeling concepts to facilitate communication regarding a particular drug development program. (TR60) (TR60-2)
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Temperature Distribution
Temperature measurement of the heating medium (e.g., forced hot air) across the chamber load zone. (TR01) (TR03) (TR30) (TR48)
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Temperature Probe/Sensor
A generic term used to describe any type of temperature measuring device that works through contact with the material or atmosphere to be measured. [Synonyms: Load Probe, Heat Penetration Probe, Temperature Distribution Probe, Drain Probe] (TR48)
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Test Article
Any food additive, color additive, drug, biologically derived product, etc., for human use or any other article subject to regulation. “Test Article,” in this report’s context, referring to the samples used for toxicity and stability studies. (TR56)
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Thermocouple
A device for measuring temperature in which a pair of wires of different metals are joined and the free ends of the wires are connected to an instrument (such as a voltmeter) that measures the electrical potential difference created at the junction of the two metals. (TR3)
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Thermometric Study
The utilization of independent temperature monitoring devices to determine a temperature profile within the load zone and analysis of the collected data. (TR3)
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Throughput
The amount of solution that passes through a filter, described as volume per membrane area. [Synonym: capacity.] (TR15) The amount of solution that passes through a filter. It is described as volume through the membrane area. [Synonym: capacity] (TR26)
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Transfer Disinfection
A disinfection process conducted on materials and equipment that coats the surface for a validated wetted time to remove bioburden prior to introducing such items into classified areas. (TR70)
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Transition Analysis
Mathematical evaluation of the chromatogram tracing as the mobile phase changes from one solution to another. An alternative to HETP and peak asymmetry for evaluating column packing and performance. (TR14)
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Trend
A statistical term referring to the direction or rate of change of a variable(s) (ICH Q9). (TR54) (TR54-2)