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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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Displaying results 1 - 50 of 56

Digital Twin

A sophisticated digital replica of a physical manufacturing process, system, or equipment, encompassing its structure, behavior, performance, and functionality. Digital twins integrate sensor and equipment data to create real-time simulations that mirror actual system behavior, enabling companies to monitor, analyze, and optimize production processes, equipment performance, and product quality. Additional benefits include predictive maintenance, process optimization, and scenario testing without disrupting real operations.

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Hyperparameter Tuning

The process of optimizing the configuration settings (hyperparameters) of a machine learning model to maximize performance. Proper tuning prevents underfitting and overfitting, improving overall accuracy.

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IT/OT (Information Technology/Operational Technology)

The merging of Information Technology (IT), which manages computing, networking, and data infrastructure, with Operational Technology (OT), which focuses on monitoring and automating physical processes. IT/OT integration enables seamless data exchange, process optimization, and enhanced system control for greater efficiency and regulatory compliance.

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Model Training

The phase in machine learning where a model learns patterns and relationships from training data, enabling it to make predictions for unseen data. Proper model training ensures generalization and reliability in real world applications.

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TCld50 Assay

Quantal assays for determining the titer of a virus. The 50% tissue culture infective does (TCID50) is the dilution of virus that results in the infection of 50% of cell cultures that have been infected with the same dilution of the virus sample. (TR47)

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Tailgate Sample

Representative and random samples of the lot taken by the manufacturer during the packing process for the use of incoming inspection purposes. (TR76)

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Tangential Flow Filtration

Filtration in which the product stream is introduced parallel to the membrane surface and flows in a direction perpendicular to the filtrate flow. (Synonym:cross-flow filtration) (TR15)

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Tangential or Cross Flow Filtration (TFF or CFF)

Filtration in which a fluid (feed) stream runs tangential to a membrane. A pressure differential causes some fluid to pass through the membrane. (TR41)

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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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Targeted Species

The range of species for which detection or analysis is aimed for by an assay method. (TR50)

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Taxonomy

The structured classification and organization of data elements into hierarchical categories and subcategories based on their relationships and attributes. Standardized data definitions and terminology streamline data management, improve retrieval, and enhance analysis across various stages of drug development and manufacturing. Taxonomies also boost interoperability, consistency, and clarity, fostering effective communication and collaboration among stakeholders.

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Technically Unavoidable Particles (TUPs)

Particles that are visibly different from the bulk of the material when viewed with the naked eye within the container or against a suitable background (e.g., size, shape, color, number, texture) and are inherent to the manufacturer’s process, product, or raw materials. The unintended presence of a small quantity of particles, stemming from impurities of natural or synthetic ingredients, the manufacturing process, storage, or migration from packaging that is technically unavoidable in good manufacturing practice, and do not pose a risk to patient safety. (TR78)

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Temperature Controlled

The sequence of transportation events, from the manufacturer of the API up to the receipt of the final packaged product by the end user, which maintains temperature sensitive products within approved temperature specifications. Maintaining temperature control during these transportation events assures that product quality is maintained. (TR39)

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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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Temperature Profile

Anticipated ambient temperature variation and duration to which product may be exposed during transportation. (TR39)

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Temperature Sensitive Products

Products whose quality may be adversely affected by temperature extremes (e.g., frozen, refrigerated, and certain controlled room temperature products). (TR39)

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Temperature-Controlled Distribution

Material handling and movement of goods from an origin site to a receiving site, where the goods are kept within a specified temperature range using active and/or passive systems. (TR58)

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Temperature-Controlled Ocean Container

An actively cooled metal box, most commonly 20 or 40 foot long which can be easily transferred between different modes of transportation, such as ships, trains and trucks. Sometimes it is called a reefer container or intermodal container. (TR58)

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Temperature-Controlled Ocean Container (Reefer, Intermodal Container)

An actively cooled metal box (commonly 20 or 40 ft long) that can be easily transferred between different modes of transportation, such as between ships, trains, and trucks. (TR64)

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Temperature-Controlled Truck or Trailer

A cargo box attached to a truck chasse or as a trailer pulled by a truck that is equipped with a temperature control unit (TCU) to provide active cooling or heating control inside the box. Refrigerated trucks or trailers are sometimes referred to as “reefers”. The temperature control units are typically powered by an integrated engine or gen-set and not the engine that is used to propel the truck. (TR58) A cargo box attached to a truck chassis or consisting of a trailer pulled by a truck that is equipped with a TCU to provide active cooling or heating control inside the box (refrigerated trucks or trailers are sometimes referred to as “reefers”). (TR64)

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Tertiary Packaging Component

A component that is used to assemble secondary or primary packages in the form of the basic transportation unit and to provide protection against mechanical impact. Examples are corrugated cardboard boxes, but corresponding plastic boxes/containers are also used. (TR39)

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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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Test Sets

A group of defect standards combined with good or blank units used to evaluate the probability of detection in visual inspection or testing system performance. Test sets can be used for inspector training, validation of automated systems, or other special studies as needed. (TR79)

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The Last Mile

This is a multidimensional cross-industry term that defines a point in the supply chain where the product or service directly faces the customer, end user or patient. (TR46)

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Thermal Mass

The mass of material present multiplied by that material’s specific heat capacity. (TR64)

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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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Thumb Pad

Disk at end of plunger rod. (TR73)

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Tissue Culture Infectious Dose – TCID50

The dilution of virus that results in the probability of infection of 50% in replicate tissue-culture inoculations. (TR41)

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Titer

The concentration of infectious virus calculated, taking into account the dilution factor. (TR41)

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Titer Reduction (TR)

A measure of the degree to which a particular filter removes a microorganism under specified test conditions. Calculated as the ratio of the total number of microorganisms used to challenge the filter divided by the total number of microorganisms that passed through the filter. (TR75)

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Token

The basic building blocks of natural language processing (NLP), created by splitting text into smaller components such as words, sub-words, or symbols. Tokens represent individual linguistic units, including words, punctuation, and numbers, enabling AI models to process and understand human language efficiently in tasks such as sentiment analysis, machine translation, and speech recognition.

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Toll-like Receptor (TLR)

A class of single membrane-spanning non-catalytic receptors that recognize structurally conserved molecules derived from microbes. They can activate immune cell responses when microbes have breached physical barriers such as the skin or intestinal tract mucosa. (TR50)

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Touchdown PCR

A technique to reduce appearance of non-specific amplicons in PCR reactions. The earliest cycles of a touchdown PCR method have high annealing temperatures. The annealing temperature is decreased in increments for subsequent cycles until a fixed point is reached. (TR50)

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Toxicity Studies (also referred to as “Tox” studies)

In vivo or in vitro experiments in which test articles are studied prospectively in test systems under laboratory conditions with the primary goals of identifying the following: 1) an initial safe dose and subsequent dose escalation schemes in humans; 2) potential target organs for toxicity and for the study of whether such toxicity is reversible; and, 3) safety parameters for clinical monitoring after the appropriate dosing and administering schedule is followed (relevant to the drug being studied). In toxicity studies, the test animals are examined by histological or serological methods in order to identify toxic, mutagenic, or teratogenic effects of the drug. It is sometimes possible to collect physiological data from the animals prior to sacrifice. Some toxicity studies may be performed using cell culture methods. Toxicity studies are also described by the U.S. FDA as “nonclinical laboratory studies” and by ICH as “preclinical safety evaluations”. The definition does not include studies using human subjects or clinical studies, field trials in animals, or any basic exploratory studies carried out to determine whether a test article has any potential utility or to determine physical or chemical characteristics as described in ICH S6 and 21 CFR Part 58 (GLP). (TR56)

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Training Data

Labeled data used to train machine learning models and algorithms to recognize patterns, make predictions, or perform other tasks. Pharmaceutical industry training data may include diverse types of data such as chemical structures, biological assays, and clinical outcomes, depending on the specific application. Applications include using training data to develop predictive models for drug toxicity, efficacy, or pharmacokinetics, based on historical data from preclinical and clinical studies. Selecting representative and high-quality training data can provide accurate and robust machine learning models that can accommodate new data and support decision-making in drug discovery and development. As best practice, training data should be documented and traceable.

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Transcription-Mediated Amplification (TMA)

An isothermal NAT method that can amplify RNA or DNA targets a billion-fold in less than one hour. TMA technology uses two primers and two enzymes: RNA polymerase and reverse transcriptase. (TR50)

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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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Transfer Learning

A machine learning technique where a pretrained model is adapted for a different but related task, often applied in cases with limited labeled data. This method accelerates training by reusing knowledge from previous learning, improving performance in pharmaceutical applications such as drug discovery, patient diagnosis, and molecular analysis.

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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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Transmembrane Pressure (TMP)

The pressure difference equal to the average feed-stream pressure minus the average filtrate-stream pressure. TMP = (Pfeed + Pretentate)/2 - Pfiltrate (TR15)

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Transmission Electron Microscopy (TEM)

A microscopy technique whereby a beam of electrons is transmitted through an ultra-thin specimen, interacting with the specimen as it passes through it. An image is formed from the electrons transmitted through the specimen, which are magnified and focused by an objective lens, and appear on an imaging screen. (TR41)

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Transport Service Provider

Contracting party who mediates or executes the transportation of medicinal products on behalf of the shipper. (TR39)

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Transportation Service Providers (TSP)

Companies that physically transport the product. (TR52)

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Transportation Study

Study performed to generate data to evaluate the effect of temperature variation on the product during transportation on product quality. Other test, such as vibration, pressure, and drop tests, may be considered. (TR39)

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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)

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True Copy (FDA)

21 CFR 211.180(d) requires records to be retained "either as original records or true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records". Electronic copies can be used as true copies of paper or electronic records, provided the copies preserve the content and meaning of the original or raw data, which includes associated metadata and the static or dynamic nature of the original records.(TR80)(TR84)

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