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 15: Validation: TFF in Biopharmaceuticals (8)
- TR 26: Sterilizing Filtration of Liquids (7)
- TR 1: Validation: Moist Heat (5)
- TR 54-2: QRM: Packaging Labeling (3)
- TR 67: Objectionable Microorganisms (3)
- TR 54: QRM:Manufacturing Operations (2)
- TR 54-3: QRM: Drug Products (2)
- TR 55: TBA/TCA Detection Mitigation (2)
- TR 3: Validation: Dry Heat (2)
- TR 14: Validation: Protein Purification Chromatography (2)
- TR 38: Manufacturing Chromatography Systems Postapproval Changes (ChromPAC) (2)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (2)
- TR 33: Rapid Micro Methods (2)
- TR 41: Virus Filtration (2)
- TR 44: QRM: Aseptic Processes (2)
- TR 45: Depth Filtration (2)
- TR 47: Virus Spikes/Virus Clearance (1)
- TR 48: Moist Heat Sterilizer Systems (1)
- TR 50: Alt. Methods Mycoplasma Testing (1)
- TR 52: Supply Chain GDP (1)
- TR 53: Stability Testing New Drug Products (1)
- TR 54-4: QRM: Biotech Drug Substance (1)
- TR 57: Analytical Method Validation (1)
- TR 57-2: Analytical Method Development (1)
- TR 58: Temp Controlled Distribution (1)
- TR 60: Process Validation (1)
- TR 61: Steam in Place (1)
- TR 62: Manual Aseptic Processes (1)
- TR 64: Temp Controlled Systems Qualification (1)
- TR 65: Technology Transfer (1)
- TR 70: Cleaning/Disinfection Programs (1)
- TR 72: Passive Thermal Protection Systems: Qualification/Operations (1)
- TR 73: Prefilled Syringe User Requirements for Biotech Applications (1)
- TR 74: Reprocessing of Biopharmaceuticals (1)
- TR 13: Environmental Monitoring (1)
- TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers (1)
- TR 29: Validation: Cleaning (1)
- TR 30: Parametric Release (1)
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- Manufacturing (48)
- Validation (33)
- Biotechnology (31)
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- GMP/Good Manufacturing Processes/cGMP (19)
- Sterile Processing (17)
- Filtration (16)
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- Technology Transfer (7)
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Formative Usability Evaluation
Observed actual or simulated use of early prototypes to help reliably identify product conceptspecific, use-related hazards that may have been missed by other methods. (TR73)
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Formulation
A listing of the ingredients and composition of the dosage form. (TR38) The percent composition of ingredients in a product. (TR67)
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Foulant
Solute or suspended solid that interacts with the membrane causing a decrease in performance (see Fouling). (TR15)
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Fouling (or Clogging)
Adsorption or interaction with components in the feed stream resulting in a decrease in membrane performance. Generally, fouling can be reversed by cleaning the membrane. (TR15) The result of solutes blinding or blocking membrane pores. It is observed as a decrease in the flux (at constant pressure) or an increase in the filtration differential pressure (at constant flux). (TR26)
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Fraction-Negative Methods
Fraction-negative methods use the starting population of a biological indicator (N0) and data in the quantal range to create a two-point line from which the DT-value can be determined. The quantal range is the exposure period over which a set of replicate test units exhibit a dichotomous response – some are positive for growth and the rest are negative for growth. (TR01)
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Frank (Canonical) Pathogens
Microorganisms responsible for infection in healthy individuals (i.e., individuals with normal operative and functional host defense mechanisms) that may be acquired from exposure to other infected people or animals, environmental reservoirs (exogenous) or the individual’s normal (endogenous) microbial flora. (TR67)
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Free Drained Equipment
No visible water pool in the equipment or line when viewed under appropriate lighting conditions (but may contain water droplets). (TR29)
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Freeze-Thaw
A study designed to determine the effect of repeated freezing (typically to -20 °C), and thawing back to labeled storage conditions (typically +5 °C for refrigerated products, and +25 °C for temperature products). Freeze-thaw studies are designed to evaluate the impact of short-term excursions where product may be exposed to sub-zero temperatures, followed by standard shipping conditions. (TR53)
Frequent Monitoring
A process of collecting data in which conditions are monitored at a defined frequency not exceeding sixty minutes during operation. In most U.S. applications, this means “during production.” (TR13)
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Frit
A porous sieve or screen installed at the top and bottom of a column used to retain chromatography resin particles and allow passage of the process stream. [Synonym: sinter] (TR14)
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Full Loop Calibration
A calibration process that includes all measurement system components, from sensor to measurement value (e.g., temperature calibration of a data logger and attached thermocouple wires). (TR64)
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Fumigation of Wood Pallets
The currently approved International Standards for Phytosanitary Measures (ISPM) fumigation method is methyl bromide (MB) fumigation and is one of the two approved phytosanitary measures in ISPM 15 (treatment and marking of wood packaging materials [WPM] that is required for international shipment. The use of methyl bromide is not permitted in some IPPC countries (e.g. the EU), and the latest ISPM 15 standard has a recommendation to reduce its use. Note: Steam heat treatment is the other ISPM 15 approved method. (TR55)