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 (6)
- TR 54-2: QRM: Packaging Labeling (3)
- TR 26: Sterilizing Filtration of Liquids (3)
- TR 54: QRM:Manufacturing Operations (2)
- TR 54-3: QRM: Drug Products (2)
- TR 67: Objectionable Microorganisms (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 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 62: Manual Aseptic Processes (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 14: Validation: Protein Purification Chromatography (1)
- TR 38: Manufacturing Chromatography Systems Postapproval Changes (ChromPAC) (1)
- TR 29: Validation: Cleaning (1)
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- Manufacturing (30)
- Validation (20)
- Quality Risk Management/QRM (17)
- GMP/Good Manufacturing Processes/cGMP (12)
- Filtration (10)
- Sterile Processing (10)
- Microbiology (9)
- Technology Transfer (6)
- Virus (2)
- Inspections (2)
- Combination Products (1)
- Outsourcing (1)
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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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Facility
A physical building with a defined building number or name. (TR38)
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Factor
Independent variables that may influence assay outcome. (May be modified with confounded, crossed, fixed, interaction, level, modifying, nested, random). (TR57) (TR57-2)
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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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False Negative
A test result that is erroneously classified in a negative category (e.g., the absence of a viable microbial detection result when viable microorganisms are present). (TR33)
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False Positive
A test result that is erroneously classified in a positive category (e.g., a viable microbial detection result when viable microorganisms are not present). (TR33)
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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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Fed-Batch Filtration Process
A modification of the batch filtration process in which a separate (typically larger) reservoir feeds a smaller recycle tank. The retentate stream is returned to the recycle tank. (TR15)
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Feed
The starting solution prior to filtration. (TR15)
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Feed (or Load or Feedstock or Feedstream)
The fluid introduced into a process. (TR41)
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Feed Pressure
The pressure measured at the inlet of the tangential flow filter device. (TR15)
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Fermentation Broth
The fluid and all constituents in a fermentation vessel prior to separation. (TR45)
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Filter
A porous medium used for the separation of components in a fluid stream.(TR15)
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Filtrate
Fluid that has been passed through a process step (filter). [Synonym: Permeate] (TR15) (TR26)
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Filtration
A process of removing particles from a fluid by passing it through a permeable material, such as a membrane film. (TR41) The process by which particles are removed from a fluid by passing the fluid through a porous material. (TR26)
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Finished Materials
This term refers to items such as drug substances, drug products, finished product held in bulk before final packaging, and clinical trial materials that are likely to be stored for significant periods of time and are also subject to the risks of distribution. (TR53)
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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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Focus Forming Unit (FFU)
A measure of virus infectively based on formation of a region or “focus”, of infected cells within a monolayer culture that is caused by viruses that do not kill their host, but rather transform them. The number of foci is directly correlated to the number of infectious virus particles. (TR47)
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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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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)