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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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Analytical Model

A mathematical or computational framework used to represent and analyze relationships between variables in drug development and manufacturing. Unlike empirical models, which rely solely on observed data, analytical models are based on theoretical principles, scientific knowledge, and mathematical equations. These models are often used to simulate and predict complex systems such as drug-receptor interactions, pharmacokinetic processes, or biopharmaceutical properties. An application for the pharmaceutical industry is describing a unit operation, such as pumping a buffer into a reaction vessel, using precise mathematical formulations.

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Auto Machine Learning (AutoML)

The automated application of machine learning techniques to design, build, and deploy AI models with minimal human intervention. AutoML platforms streamline model selection, feature engineering, hyperparameter tuning, and evaluation, making machine learning more accessible. In pharmaceuticals, AutoML accelerates drug discovery, predictive modeling of patient outcomes, and manufacturing process optimization.

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Confusion Matrix

A structured table used to evaluate the accuracy of a classification model, displaying true positive, true negative, false positive, and false negative counts. It helps identify model strengths and areas for improvement.

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Hybrid Model

A computational model that combines elements from multiple modeling approaches, such as empirical, mechanistic, and machine learning techniques, to solve complex problems. By leveraging the strengths of each approach, hybrid models enhance predictive accuracy, robustness, and interpretability. Applications include integrating mechanistic drug metabolism models with machine learning algorithms trained on experimental data to predict the pharmacokinetic behavior of new drug candidates. Similarly, hybrid models can merge empirical data with physiological knowledge to simulate drug-disease interactions or optimize formulation designs.

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Machine Learning (ML)

A specialized branch of artificial intelligence (AI) that utilizes algorithms and statistical models to process data, generate insights, make predictions, and provide recommendations within complex datasets. In the Pharmaceutical industry, ML identifies patterns, trends, and anomalies within complex datasets derived from drug discovery, clinical trials, manufacturing, regulatory compliance, pharmacovigilance, and patient outcomes. Companies leverage ML to streamline drug discovery, improve manufacturing efficiency, enhance quality control, personalize patient treatments, and expedite regulatory approvals.

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Magnetic Capture Hybridization (MCH)

A purification method based on sequence-specific hybridization of labeled nucleic acid probes with targeted regions of test article nucleic acids, followed by magnetic bead capture. (TR50)

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Mandrel

Specialized filling needles on certain BFS machines which also act to form the container. (TR77)

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Manual Baseline

Data generated from visual inspection of a blinded set of seeded test containers that demonstrates the detection capability of human inspection. The test set is sometimes referred to as a “particle size threshold set,” where various foreign particulate types in a gradation of sizes are examined to yield a statistically significant probability of detection percentage for each unit. This allows the determination of what types and sizes of particulates can be reproducibly detected in a specific product/container system. (TR79)

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Manual Inspection

Consists of manual handling and presentation of filled containers under controlled conditions of lighting and background to allow for human visual inspection. (TR79)

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Manufacturing

The production, packing, testing, storage, release and distribution of drugs or medical devices for use in humans or animals where the manufacturing is indented to produce doses, typically in significant numbers, for an undefined population of future patients or clinical trial subjects. (TR63) All operations including purchasing and receipt of materials to production, packaging, labelling, quality control, release, storage, distribution of components and the related controls. (TR 76)

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Manufacturing System Lifecycle

All phases in the life of a manufacturing system from the initial development until the manufacturing system retirement, including specification design, fabrication, installation, commissioning, qualification, operation, maintenance, change, decommissioning and retirement. (TR54-5)

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Marketing Authorization Application (MAA)

An application submitted by a sponsor to the European Medicines Agency (EMA) for approval to market a new drug for human use in Europe. The MAA is similar in purpose to the Biologic License Application (BLA) or New Drug Application (NDA) in the United States. (TR56)

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Masking

A type of interference that may result in low endotoxin recovery.(TR82)

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Mass Spectroscopy

An analytical test method for identifying the chemical composition of a sample by separating its gaseous component ions according to their mass and charge. (TR26)

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Master Cell Bank (MCB)

The MCB represents a collection of cells of uniform composition derived from a single source prepared under defined culture conditions. (TR 54-4) The MCB represents a collection of cells of uniform composition derived from a single source prepared under defined culture conditions, aliquoted into multiple vials, cryopreserved and stored in the vapor phase of liquid nitrogen. (TR 83)

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Master Cell Bank (mCb)/Master Virus Bank (mVb)

A stock of cells or virus used to produce the Working Cell Bank or the Working Virus Bank. Cell/virus banking is used to enhance biological consistency. (TR47)

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Master Seed Stock

Reference culture of a microorganism derived from an authenticated source such as American Type Culture Collection (ATCC) and used to produce working seed lots. (TR51)

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Material Safety Data Sheet (MSDS)

Information provided with chemicals and other materials intended to provide workers and emergency personnel with procedures for handling or working with that substance in a safe manner. Includes information such as physical data (melting point, boiling point, flash point, etc.), toxicity, health effects, first aid, reactivity, storage, disposal, protective equipment, and spill-handling procedures. (TR65)

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Materials of Construction

Polymers or other materials that make up the components of the filter. (TR26)

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Matrix

The combination of materials (e.g., excipients, stabilizer components, etc.) which are components together with the measured analyte. (TR57)

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Matrix Effect

The direct or indirect alteration or interference in response due to the presence of additional sample components due to sample preparation (for analysis) or other interfering substances in the sample (product related excipients or residuals). (TR57) (TR57-2)

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Matrix Spike Control

An internal control in which an amplifiable amount of nucleic acid is added to a test article to determine inhibition of the PCR. This addition is usually performed pre-extraction and should provide a weak signal 100% of the time. Also known as “interference control”. (TR50)

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Maximum Allowable Leak Limit (MALL)

The greatest gap or leak rate that does not put product quality at risk (2). (TR86)

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Maximum Load

The maximum quantity or mass of items permitted in a sterilizer load. (TR01) The maximum quantity or mass of items permitted in a depyrogenation or sterilization load. (TR3) The maximum quantity or mass of products permitted in a validated sterilizer load. (TR30)The maximum quantity or mass of items permitted in a sterilizer load. (TR48)

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Mean Kinetic Temperature (MKT)

The single calculated temperature at which the total amount of degradation over a particular period is equal to the sum of the individual degradations that would occur at various temperatures. Thus, MKT may be considered as an isothermal storage temperature that simulates the nonisothermal effects of storage temperature variation. It is not a simple arithmetic mean. (TR46) (TR58)

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Meaningful Disruption

A meaningful disruption is a change in production that is reasonably likely to lead to a reduction in the supply of a drug by a manufacturer that is more than negligible and affects the ability of the manufacturer to fill orders or meet expected demand for its product. A meaningful disruption is not an interruption in manufacturing due to matters such as routine maintenance and does not include insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short period of time. (TR68)

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Measured Values

Those values where activity is confirmed by interpolation from a reference standard curve.(TR82)

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Media

The part of the filter through which fluid passes that retains particles during filtration. (TR45)

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Medically Necessary Drug

Any drug product used to diagnose, treat, or prevent a serious disease or medical condition for which no other drug is judged to be an appropriate substitute or there is an inadequate supply of an acceptable alternative as determined by the relevant health authority. (TR68)

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Medicinal Product

Any product intended for the diagnosis, treatment, or prevention of disease. (TR39)

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Medium

In filtration, the porous material which retains particles as a fluid passes through during the process of filtration (TR26)

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Melting Temperature (Tm)

The calculated or observed temperature for a primer/nucleic acid mixture at which 50% of primer-binding sites are in single strand form. (TR50)

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Membrane

A thin, microporous medium used to remove particles and microorganisms from a fluid stream under pressure. (TR26) Analytical technique to collect particles from a liquid sample on a membrane filter followed by manual examination (sizing and counting) with a microscope. (TR85)

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Metabolite

A substance that is either the result of metabolism or a requirement for a metabolic process. (TR70)

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Metadata

Descriptive information that provides context and additional details about a dataset, such as its origin, structure, and meaning. Metadata plays a crucial role in the pharmaceutical industry in ensuring data quality, integrity, and interoperability across different systems and applications. This may include information about the source of a dataset, the methodology used to collect and process the data, and the relevant standards and conventions followed. In drug development, metadata can help researchers and regulators understand the provenance and reliability of experimental data, facilitate data sharing and collaboration, and support regulatory compliance and auditability.

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Metadata (FDA)

The contextual information required to understand data. A data value is by itself meaningless without additional information about the data. Metadata is often described as data about data. Metadata is structured information that describes, explains, or otherwise makes it easier to retrieve, use, or manage data.(TR80)

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Metadata (MHRA)

Metadata is data that describe the attributes of other data and provide context and meaning. Typically, these are data that describe the structure, data elements, inter-relationships and other characteristics of data. It also permits data to be attributable to an individual (or if automatically generated, to the original data source).(TR80)

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Metadata (WHO)

Metadata are data about data that provide the contextual information required to understand those data. These include structural and descriptive metadata. Such data describe the structure, data elements, interrelationships and other characteristics of data. They also permit data to be attributable to an individual.(TR80)

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Method Comparability

The demonstration of analytical method comparability (AMC) for method replacements. A study to demonstrate that a modification to an existing method either improves or does not significantly change the analytical procedure’s characteristics relative to the methods’ validation and intended use. (TR57)

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Method Development

A process that involves the selection, optimization, and qualification of a physical/chemical, biological, molecular, or microbiological test procedure. (TR57)

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Method Lifecycle

All stages in the life of a method, from the initial development through marketing, until the method’s discontinuation. (TR57-2)

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Method Parameter

Any factor or method operational step that can be varied continuously (e.g., flow rate) or specified at controllable unique levels (e.g., Gas Chromatograph liner type).

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Method Qualification

Formal or informal study performed to assess initial method performance prior to full ICH Q2 (R1) validation; assessment activity that culminates in a scientifically sound method that has an acceptable level of performance and is documented to be suitable for its intended use. (TR56) Experimental studies performed to confirm the inherent performance capabilities of a test method for the material being analyzed and the intended use of the method. Method qualification can be performed during early development phases, prior to method validation. Specific method qualification characteristics (e.g., accuracy, specificity) should be confirmed based on the intended use of the analytical method and the relevant risk(s). (TR57)

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Method Validation

A formal, archived demonstration of the analytical capacity of an assay that provides justification for use of the assay for an intended purpose. (TR56) A formal, archived demonstration of the analytical capacity of an assay that provides justification for use of the assay for an intended purpose. Validations are conducted prospectively according to a written, approved plan that states acceptance criteria. (TR57) (TR57-2)

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Method, Qualitative

An analytical procedure, based on the characteristics of a material that yields results that are not amenable to reliable enumeration. (TR57)

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Method, Quantitative

An analytical procedure that yields numerical results compared to quantitative specification(s). (TR57)

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Micro-condensation

The formation of very fine layers of condensation often invisible to the naked eye. (TR51)

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Microbial Classification

The arrangement of microorganisms into taxonomic groups based on their similarities and relationships. (TR13)

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Microbial Count Determination

A test performed to quantify the number of microorganisms present in a sample of material. Standard microbial methods are utilized to estimate the number of colony forming units (CFU) per unit mass or volume. (TR28)

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Microbial Enumeration

Compendial test for microbial counts using the plate-count, membrane-filtration or most probable number methods described in USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumerations Tests. (TR67)

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