PDA Technical Glossary
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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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Quality Risk Management/QRM
FDA Form 483
Inspectional observation sheet used by FDA investigators to document their findings. (TR67)
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Facilitator
Independent QRM expert who facilitates risk assessment; guides documentation, risk control, and risk review; and helps present risk assessment results and risk control proposals. (TR54-2) (TR54-5)
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Failure
The condition or fact of not achieving expected results; a cessation of proper functioning or performance. (TR44)
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Failure Effect
An impact on customer requirements. Generally, failure effect has an external customer focus, but it can also include downstream processes. (TR58)
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Failure Mode and Effects Analysis (FMEA)
A method of assessing and evaluating risk. (TR44) A systematic method for identifying, analyzing, prioritizing and documenting potential failure modes, their effects on system, product and process performance, and the possible causes of failure in order to prevent defects from occurring. (TR54) (TR54-2) (TR54-3) (TR54-4) (TR74) (TR54-5) A tool for analyzing processes or systems to evaluate all operating steps in order to identify and assess the risk associated with any potential failures. (TR65) An analytical technique that results in a rankordered list of concerns to take action on. (TR72)
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Fastidious strain (isolate)
A population of microorganisms having complex nutritional requirements and thus difficult to cultivate. (TR50)
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Fault Tree Analysis (FTA)
A deductive technique used to analyze the causes of faults (defects). The technique visually models how logical relationships between failures, human errors, and external events can combine to cause specific faults. (TR54) (TR54-2) (TR54-3) (TR54-5)
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Fermentation Broth
The fluid and all constituents in a fermentation vessel prior to separation. (TR45)
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First Air
Refers to the air exiting at the face of HEPA filters. Based on the airflow through HEPA filters and its unidirectional air flow the air exiting at the filter face is for the purposed of aseptic processing free of particulate contamination (both viable and non-viable). (TR70)
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First Air (First Work Location)
The work location first in the path of HEPA filtered air. (TR62)
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First Expiration, First Out (FeFo)
A method of controlling inventory to ensure that the material with the shortest remaining shelf-life is distributed first. (TR52)
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Flow Decay Test
An experiment to determine flow rate and throughput of a filter type or combination of filters on a specific liquid, usually by using a small area filter, to determine the sizing of a filter system by extrapolation. (TR45)
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Flow Rate
The volumetric rate of flow of a solution, expressed in units of volume per time (e.g., L/min or gal/day). (TR15) (TR26)
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Flow-through
Effluent that may contain the product that is not retained by chromatography resin during column loading. (TR14)
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Formal Experimental Design (Synonym – Design of Experiments)
A structured, organized method for determining the relationship between factors affecting a process and the output of that process. (TR60)
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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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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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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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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)
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