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.

(Please select "All" to restart a filtered Search)

  • All
  • 0
  • 1
  • 2
  • 3
  • 4
  • 5
  • 6
  • 7
  • 8
  • 9
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z
Analytical Method Transfer (AMT)
Documented process that qualifies a laboratory (receiving unit) to use an analytical test procedure that originates in another laboratory (the transferring unit, also known as the sending unit), thus ensuring that the receiving unit has the knowledge and ability to perform the transferred analytical procedure as intended. (TR57-2)
Source:
Comparative Transfer
Transfer of a method that involves the analysis of a predetermined number of samples of the same lot by both the sending and the receiving unit. (TR 57-2)
Source:
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)
Source:
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)
Source:
Factor
Independent variables that may influence assay outcome. (May be modified with confounded, crossed, fixed, interaction, level, modifying, nested, random). (TR57) (TR57-2)
Source:
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)
Source:
Method Lifecycle
All stages in the life of a method, from the initial development through marketing, until the method’s discontinuation. (TR57-2)
Source:
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)
Source:
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)
Source:
Relative Accuracy
Attribute determined after demonstration of precision, linearity, and specificity under deliberately varied conditions, such as across a range of sample dilutions in the presence of matrix interference. (TR57-2)
Source:
Secondary (Working, In-house) Reference Standard
Substance of established quality and purity that is qualified against, and used instead of, the primary reference standard; typically used as a reference standard for routine laboratory analysis. (TR57-2)
Source:
Sensitivity
Ability of a method to detect small changes in the quality attribute (e.g., changes in concentration or purity) being measured. (TR57-2)
Source:
Stress Studies (Degradation Pathway Studies)
Studies undertaken to elucidate the intrinsic stability of the drug substance and/or drug product; part of the development strategy and normally carried out under more severe conditions (e.g., high or low pH or oxidation levels, or shaking) than those used for accelerated testing. (TR57-2)
Source:
Target Criteria
Numerical limits, ranges, or other suitable measures of target performance levels of an analytical method that indicate suitable performance for intended use. For a method entering qualification, this is a target performance criterion that, when assessed, indicates that the method is qualified for its intended purpose. (TR57-2)
Source: