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 (5)
- TR 50: Alt. Methods Mycoplasma Testing (4)
- TR 56: Phase Appropriate cGMP Application (3)
- TR 67: Objectionable Microorganisms (3)
- TR 1: Validation: Moist Heat (3)
- TR 51: Biological Indicators (2)
- TR 57-2: Analytical Method Development (2)
- TR 13: Environmental Monitoring (2)
- TR 79: Particulate Matter Control in Difficult to Inspect Parenterals (2)
- TR 29: Validation: Cleaning (2)
- TR 45: Depth Filtration (2)
- TR 61: Steam in Place (1)
- TR 70: Cleaning/Disinfection Programs (1)
- TR 15: Validation: TFF in Biopharmaceuticals (1)
- TR 22: Aseptic Process Simulation (1)
- TR 26: Sterilizing Filtration of Liquids (1)
- TR 75: Mycoplasma Filter Rating Method (1)
- TR 82: Low Endotoxin Recovery (1)
- TR 28: Process Simulation for Bulk API (1)
- TR 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology (1)
- TR 41: Virus Filtration (1)
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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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Masking
A type of interference that may result in low endotoxin recovery.(TR82)
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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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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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Metabolite
A substance that is either the result of metabolism or a requirement for a metabolic process. (TR70)
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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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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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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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Mycoplasma Reduction Filter
A sterilizing grade filter that also provides a log reduction value (or a titer reduction value) for a specified test mycoplasma according to the PDA Mycoplasma Consensus Method. (TR75)