PDA Technical Glossary

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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Acceptance Criteria
Numerical limits, ranges, or other suitable measures for acceptance of test results. (TR 14) (TR 29) (TR 38) (TR 64) Numerical limits, ranges, or other suitable measures for acceptance of test results. Exceeding the acceptable range for a critical parameter during subsequent validation studies may result in questionable product quality that would require initiation of an investigation. Exceeding the operating range should be documented and explained in the validation report and evaluated for validation study impact. (TR 42) The pre-defined specifications, standards or ranges that must be met under stated test conditions. (TR 48) Numerical limits, ranges, or other suitable measures for acceptance of the results of analytical method validation that is satisfied to determine suitability of test method performance.(TR 57) (TR 69) (TR 72) (TR 74) The criteria that a system or component must satisfy in order to be accepted by a user or other authorized entity. (TR 54-5) Numerical limits, ranges, or other suitable measures for acceptance of the results of analytical procedures which the drug substance or drug product or materials at other stages of their manufacture should meet (16). Exceeding the acceptable range for a critical parameter during subsequent validation studies may result in questionable product quality that would require initiation of an investigation and possible batch rejection. (TR60)
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Accuracy
The closeness of the actual test results obtained by the new method to the actual test results obtained by the existing method. (TR33) An analytical procedure expresses the closeness of agreement between the value that is accepted either as a conventional true value or an accepted reference value and the value found. This is sometimes termed trueness. (TR57)
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Analysis of Variance (ANOVA)
A general statistical approach to data analysis (i.e., comparison of means) in which the variation in a method’s results is partitioned among explanatory factors in order to systematically assess factor influence and/or variance components. (TR57)
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Analyte
Substance (usually a residue) for which an analysis is being performed. (TR29) (TR49) (TR70) A specific chemical moiety being measured, which can be intact drug, biomolecule or its derivative, impurity, and/or excipients in a drug product. [Synonym: measurand] (TR57)
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Analytical Instrument Qualification (AIQ)
The qualification of the analytical instrument(s) used as part of the analytical procedure. (TR57)
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Analytical Method Comparability (AMC)
Equivalence study that measure the same property of two methods and that shows that replacing one of these methods with the other would not adversely affect the test’s use or results. (TR57-2)
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Analytical Platform Technology (APT)
An analytical method that is used for multiple products and/or types of sample matrix without modification of the procedure. Similar to compendial methods, an APT method may not require full validation for each new product or sample type. (TR57)
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Analytical Procedure
That which is performed in order to obtain a reportable result. The procedure should describe in detail the steps necessary to perform the analytical test. This may include but is not limited to: the sample, the reference standard and the reagents preparations, use of the apparatus, generations of the calibration curve, use of the formulae for the calculation [Synonym: Method, Assay] (TR57)
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Bias
A systematic difference in a method that manifests itself as a deviation of the method mean from an expected value. (TR57) Total systematic error, in contrast to random error. Measurement centered on the true result is said to be unbiased or have no systematic error. The distance between the center of a large (infinite) number of measurements and the correct value is the bias. (TR 57-2)
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Bioanalytical Test Method
A method used to assess the presence of analytes (chemical or biological) in biological samples (e.g., serum, plasma, etc.). (TR57)
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Bioassay
Analysis (as of a drug) to quantify the biological activity(ies) of one or more components by determining its capacity for producing an expected biological activity. (TR57)
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Biological Activity
Property that describes the specific ability or capacity of a product to achieve a defined biological effect. (TR57)
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Calibration Curve
The relationship between measured response values and analytical concentrations of a standard or reference material. (TR57)
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Compendial Procedure
Contaminant
Any adventitiously or externally introduced material(s) (e.g., chemical, biochemical, or microbial species) not intended to be part of the process. (TR14) (TR15) (TR70) An undesired impurity of a chemical or microbiological nature that is introduced into a raw material, intermediate, or API (drug substance) during manufacture. (TR14) (TR15) Any adventitiously introduced materials (e.g., chemical, biochemical, or microbial species) not intended to be part of the manufacturing process of the drug substance or drug product. (TR69) (TR74) Any adventitiously introduced material (e.g., chemi­cal, biochemical) or microorganisms including viruses not intended to be included in the manufacturing process of the drug substance or drug product. (TR83)
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Correlation Coefficient ( r )
A measure of covariation, the square root of the coefficient of determination. (TR57)
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Critical Reagent
A component of the test method that may have a substantial impact on the consistency and reliability of method performance. Features of critical reagents include: 1. A reagent that requires qualification of each new batch prior to routine use in an analytical procedure, or 2. A material whose method performance characteristics may change over time, during handling, or from lot to lot. 3. An analytical reagent that may be purchased only from a single vendor. Reagent Examples: antibodies or enzymes that require titration prior to use, tissue culture treated plates when only one vendor’s plates give acceptable results for a bioassay, growth factors for bioassay cells, conjugated proteins that require custom preparations, or reference or system suitability standards. (TR57) Function related: assay reagents that have been shown through development and/or robustness studies to have the potential to generate measurable differences that can significantly affect assay performance, such as sensitivity, specificity, and precision. (TR57-2)
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Degradation Product
Molecular variants resulting from changes in the desired product or product-related substance brought about over time and/or by the action of light, temperature, pH, water, etc., or by reaction with an excipient and/or the immediate container/ closure system. Such changes may occur because of manufacture and/or storage (e.g., deamidation, oxidation, aggregation, proteolysis). Degradation products may be either product-related substance or product-related impurities. (TR57)
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Design of Experiments (DOE)
A method for carrying out carefully planned experiments on a process. Usually, DoE involves a series of experiments that initially involves evaluating many variables and then focuses on a few critical ones. (TR54-4) A structured, organized method for determining the relationship between factors affecting an assay and output of that assay. (TR57) (TR57-2) (TR74) A structured, organized method for determining the relationship between factors affecting a process and the output of that process (8). (TR60)
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Drug Product (DP)
A pharmaceutical product type that contains a drug substance, generally, in association with excipients. [Synonym: Dosage Form; Finished Product] (TR57)(TR14)(TR42) A finished dosage form (e.g., tablet, capsule, or solution) that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients.(TR38) (TR67) (TR88) The dosage form in the final immediate packaging intended for marketing.(TR60)(TR82)
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Drug Substance (DS)
The active ingredient that is subsequently formulated with excipients to produce the drug product. It can be composed of the desired product, product-related substances, and product- and process-related impurities. It may also contain excipients, including buffers and other components. [Synonyms: bulk drug substance, bulk material, active pharmaceutical ingredient (API)] (TR14) (TR57) (TR74) (TR60) Active pharmaceutical ingredient in a drug product that is responsible for that product’s therapeutic activity.(TR67) (TR82) (TR88) See Active Pharmaceutical Ingredient (API). (TR56)
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Equivalence Margin
The largest difference between the results from two methods that is considered as being scientifically and statistically acceptable. (TR57)
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Error
Deviation from expected value. Error may be random or systematic. (TR57)
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Excipient
A component of a drug formulation that has no active pharmacologic function. Excipients are commonly used in drug formulations as modulators of pH or osmolality for parenteral administration and as stabilizers for APIs. (TR54-4) An ingredient added intentionally to the drug substance that should not have pharmacological properties in the quantity used. (TR57) Inactive pharmaceutical ingredients in a product formulation that are responsible for the product’s manufacturability and physicochemical attributes. (TR67) (TR88)
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Factor
Independent variables that may influence assay outcome. (May be modified with confounded, crossed, fixed, interaction, level, modifying, nested, random). (TR57) (TR57-2)
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Identification
Use of an analytical procedure to determine the chemical and biochemical identity of a material. (TR57)
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Impurity
Any component present in the drug substance or drug product that is not the desired product, a product-related substance, or excipient including buffer components. It may be either processor product-related. (TR14) (TR57) (TR74) Any component present in the drug substance or drug product which is not the desired product, a product-related substance, or excipient. It may be either process- or product-related (17). (TR60)
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Independent Replicates
Two or more measurements or observations that are generated from independently prepared samples and do not affect each other. (TR57)
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Limit, Detection (DL)
The lowest amount of analyte in a sample that can be detected but not necessarily quantitated as an exact value by an individual analytical procedure. [Synonym: Limit of detection (LOD)] (TR57)
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Limit, Quantitation (QL)
The lowest amount of analyte is a sample that can be quantitatively determined with suitable precision and accuracy by an individual analytical procedure. [Synonym: Limit of quantitation (LOQ)] (TR57)
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Linearity
The ability to elicit results that are proportional to the concentration of microorganisms present in the sample within a given range, where accuracy and precision are demonstrated. (TR33) The linearity of an analytical procedure is its ability (within a given range) to obtain test results that are directly proportional to the concentration (amount) of analyte in the sample. (TR57)
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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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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 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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Noninferiority
A comparison with the primary objective of showing that the result from one method is not inferior to the method being compared. This is usually demonstrated by showing that the true difference is likely to lie above the lower equivalence margin. (TR57)
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Potency
The measure of the biological activity using a suitably quantitative biological assay, based on the attribute of the product that is linked to the relevant biological properties. (TR57) An expression of the activity of a secondary calibration standard to relate units of weight (ng/ vial or ng/mL) to units of activity (EU/ng) in a preparation.(TR82)
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Precision
The degree of agreement among individual test results when the procedure is applied repeatedly to multiple samplings of the same suspension of microorganisms and using different suspensions across the range of the test. Also known as repeatability. (TR33) The closeness of agreement (degree of scatter) between a series of measurements obtained from multiple sampling of the same homogeneous sample under the prescribed conditions. Precision may be considered at three levels: repeatability, intermediate precision, and reproducibility. It is usually expressed as the variance, standard deviation, or coefficient of variation of a series of measurements. (TR57)
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Precision, Intermediate
The closeness of agreement between a series of measurements obtained within laboratory variations (e.g., different days, different analysts, different equipment). (TR57)
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Precision, Reproducibility
The closeness of agreement between a series of measurements for the same sample obtained among different laboratories. (TR57)
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Process Validation
The documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce an intermediate or API (drug substance) meeting its predetermined specifications and quality attributes. (TR14) (TR42) Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. (TR44) The collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality products. (TR54) (TR57) (TR74) The collection and evaluation of data, from the pro­cess design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. The documented evidence that the process, op­erated within established parameters, can per­form effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes, as described in EMA, EU GMP, Part 1, Annex 15, drug/me­dicinal product. (TR56) EMA: The documented evidence that the process, op­erated within established parameters, can per­form effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes. US FDA: The collection and evaluation of data, from the process design stage through commercial pro­duction, which establishes scientific evidence that a process is capable of consistently deliver­ing quality products. (TR60-2) The documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce an intermediate or drug substance meeting its predetermined specifications and quality attributes (1, 17). (TR60-3)
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Quality Attribute
A molecular or product characteristic that is selected for its ability to help indicate the quality of the product, such as identity, purity, potency stability and safety. (TR57) (TR57-2) A molecular or product characteristic that is selected for its ability to indicate the quality of the product. Collectively, the quality attributes define identity, purity, potency, and stability of the product, and safety with respect to adventi­tious agents. Specifications measure a selected subset of the quality attributes. (TR60-2)
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Quality Risk Management (QRM)
A systematic process for the assessment, control, communication, and review of risk to the quality of the drug product across the product lifecycle.(TR43)(TR54-2)(TR54-3)(TR57)(TR67)(TR68) Documentation to prove that an installation/ equipment/process is designed and/or tested according to predefined specifications. Documentation may include Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).(TR58) A systematic process for the assessment, control, communication, and review of risks to the quality of the drug (medicinal) product across the product lifecycle.(TR 54-5)(TR 76)(TR88)
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Recovery
The mass of desired solute in the final product solution (either permeate or retentate, depending on the process), divided by the mass of the desired solute in the initial feed solution, expressed as a percentage. [Synonym: yield] (TR15) (TR45) A measure of the amount of analyte carried through the entire sample preparation and assay procedure and expressed as a percentage of the nominal concentration. (TR57)
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Regression
A mathematical model in which the response of a dependent variable is a function of change in an independent variable, such as is seen in a concentration-response curve. Regression may be linear (e.g., a straight line) or non-linear (e.g., four parameter logistic). (TR57)
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Repeatability
The precision under the same operating conditions over a short interval of time. (TR57)
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