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 57: Analytical Method Validation (8)
- TR 56: Phase Appropriate cGMP Application (4)
- TR 1: Validation: Moist Heat (4)
- TR 57-2: Analytical Method Development (3)
- TR 50: Alt. Methods Mycoplasma Testing (2)
- TR 29: Validation: Cleaning (2)
- TR 46: Good Distribution: Last Mile (1)
- TR 47: Virus Spikes/Virus Clearance (1)
- TR 48: Moist Heat Sterilizer Systems (1)
- TR 51: Biological Indicators (1)
- TR 54-4: QRM: Biotech Drug Substance (1)
- TR 58: Temp Controlled Distribution (1)
- TR 61: Steam in Place (1)
- TR 3: Validation: Dry Heat (1)
- TR 26: Sterilizing Filtration of Liquids (1)
- TR 83: Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response (1)
- TR 30: Parametric Release (1)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (1)
- TR 45: Depth Filtration (1)
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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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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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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 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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Media
The part of the filter through which fluid passes that retains particles during filtration. (TR45)
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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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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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Microdosing Studies
Studies designed to speed up the development of promising drugs by establishing early on whether the drug or agent behaves in human subjects as was expected from preclinical studies. May include the administration of single subtherapeutic doses of the study drug to a small number of subjects (10 to 15) to gather preliminary data on the agent’s pharmacokinetics and pharmacodynamics. A Microdosing study gives no data on safety or efficacy, being by definition a dose too low to cause any therapeutic effect. (TR56)
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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)