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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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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 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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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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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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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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Measured Values

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

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Medicinal Product

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

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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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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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Microbial Identification

The determination of the genus, and species when possible, to which a laboratory or manufacturing isolate belongs. (TR13)

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Microbiological Examination Tests

The compendial tests for microbial enumeration and absence of specified microorganisms as found in USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumerations Tests and USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms. (TR67)

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Microbiological Identification

Biochemical characterization of isolated colonies to determine the isolate genus and, where feasible and appropriate, the species. (TR22)

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Microfiltration (MF)

Pressure-driven, membrane-based separation process in which particles and dissolved macromolecules (typically 0.1 &mum or larger) are retained. (TR15)

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Microorganism

A microbe; a free-living organism too small to be seen by the naked eye. (TR45) (TR26)

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Microorganism of Concern

A bacterium, yeast, or mold that, due to it prominence in product recalls, infection outbreaks, nosocomial infections, and the clinical literature, results in a multifactor risk assessment to determine whether the microorganism is objectionable if it is present in a specific nonsterile product. (TR67)

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Minimum Acceptable Cycle (MAC)

The minimum cycle conditions (in terms of delivered minimum lethality or minimum time and temperature) that would be considered acceptable. (TR01) (TR61)

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Mixed Load

A load that contains multiple item item types representing various sterilization challenges. For example, some load items may have air removal challenges, while others pose a challenge due to their mass. (TR01)

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Mock Soil

A soil which is used in place of the manufactured product during a cleaning validation protocol (also called a “surrogate” soil). (TR29)

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Mock Soiling

A process of soiling the equipment for a cleaning validation protocol in which soil is applied to the equipment surfaces to simulate the condition of the soil on those surfaces following typical product manufacturing. (TR29)

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Moist Heat

Steam, steam-air mixtures, and superheated water used for sterilization. (TR01)

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Mollicutes

A class of bacteria which lack a cell wall. Mollicutes are small, typically about 0.1-0.5 &mum in size, and vary in form (trivial name: mycoplasma) (TR50)

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Monodispersed particles

Particles of uniform size in a dispersed phase. In the case of viruses, this term refers to free virus particles not agglomerated to other viruses or proteins in solution. (TR41)

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Most Probable Number (MPN) Method

A statistical method of estimating the number of viable organisms suspended in a liquid. (TR51)

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Multi-Use System (MUS)

An engineered process equipment solution for process management and unit operations designed for repeated use. (TR66)