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 50: Alt. Methods Mycoplasma Testing (1)
- TR 52: Supply Chain GDP (1)
- TR 54: QRM:Manufacturing Operations (1)
- TR 54-2: QRM: Packaging Labeling (1)
- TR 54-3: QRM: Drug Products (1)
- TR 60: Process Validation (1)
- TR 62: Manual Aseptic Processes (1)
- TR 67: Objectionable Microorganisms (1)
- TR 70: Cleaning/Disinfection Programs (1)
- TR 73: Prefilled Syringe User Requirements for Biotech Applications (1)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (1)
- TR 45: Depth Filtration (1)
Filter By Technical Report Keyword
Filter By Technical Report Category
FDA Form 483
Inspectional observation sheet used by FDA investigators to document their findings. (TR67)
Source:
Fastidious strain (isolate)
A population of microorganisms having complex nutritional requirements and thus difficult to cultivate. (TR50)
Source:
Fault Tree Analysis (FTA)
A deductive technique used to analyze the causes of faults (defects). The technique visually models how logical relationships between failures, human errors, and external events can combine to cause specific faults. (TR54) (TR54-2) (TR54-3) (TR54-5)
Source:
Fermentation Broth
The fluid and all constituents in a fermentation vessel prior to separation. (TR45)
Source:
First Air
Refers to the air exiting at the face of HEPA filters. Based on the airflow through HEPA filters and its unidirectional air flow the air exiting at the filter face is for the purposed of aseptic processing free of particulate contamination (both viable and non-viable). (TR70)
Source:
First Air (First Work Location)
The work location first in the path of HEPA filtered air. (TR62)
Source:
First Expiration, First Out (FeFo)
A method of controlling inventory to ensure that the material with the shortest remaining shelf-life is distributed first. (TR52)
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)