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)
Refine Results
Filter By Technical Report Number
- TR 33: Rapid Micro Methods (2)
- TR 57: Analytical Method Validation (1)
- TR 57-2: Analytical Method Development (1)
- TR 60: Process Validation (1)
- TR 67: Objectionable Microorganisms (1)
- TR 73: Prefilled Syringe User Requirements for Biotech Applications (1)
- TR 15: Validation: TFF in Biopharmaceuticals (1)
- TR 38: Manufacturing Chromatography Systems Postapproval Changes (ChromPAC) (1)
Filter By Technical Report Keyword
Filter By Technical Report Category
Factor
Independent variables that may influence assay outcome. (May be modified with confounded, crossed, fixed, interaction, level, modifying, nested, random). (TR57) (TR57-2)
Source:
False Negative
A test result that is erroneously classified in a negative category (e.g., the absence of a viable microbial detection result when viable microorganisms are present). (TR33)
Source:
False Positive
A test result that is erroneously classified in a positive category (e.g., a viable microbial detection result when viable microorganisms are not present). (TR33)
Source:
Fed-Batch Filtration Process
A modification of the batch filtration process in which a separate (typically larger) reservoir feeds a smaller recycle tank. The retentate stream is returned to the recycle tank. (TR15)
Source:
Formal Experimental Design (Synonym – Design of Experiments)
A structured, organized method for determining the relationship between factors affecting a process and the output of that process. (TR60)
Source:
Formative Usability Evaluation
Observed actual or simulated use of early prototypes to help reliably identify product conceptspecific, use-related hazards that may have been missed by other methods. (TR73)
Source:
Formulation
A listing of the ingredients and composition of the dosage form. (TR38) The percent composition of ingredients in a product. (TR67)