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 60: Process Validation (3)
- TR 70: Cleaning/Disinfection Programs (2)
- TR 47: Virus Spikes/Virus Clearance (1)
- TR 48: Moist Heat Sterilizer Systems (1)
- TR 55: TBA/TCA Detection Mitigation (1)
- TR 62: Manual Aseptic Processes (1)
- TR 1: Validation: Moist Heat (1)
- TR 22: Aseptic Process Simulation (1)
- TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry (1)
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Adverse Event (AE) Report
An AE report is a communication to the U.S. FDA of an undesirable sign or symptom associated with use of a drug as required and detailed by 21 CFR 314.80. These reports are logged into the U.S. FDA’s Adverse Event Reporting System (AERS). Drug manufacturers are required to report adverse event information to FDA. These reports may also may be voluntarily submitted to the FDA directly by healthcare professionals or the general public at Med Watch. The reports are reviewed, safety issues are monitored, and data are periodically analyzed and assessed by the Center for Drug Evaluation and Research (CDER). (TR55)
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Adverse Trend
A series of alert-level or action-level excursions that indicates the system or areas are not in control and have the potential to affect the product quality. (TR 70)
An increase in the frequency of alert- and action-level excursions or repeated recovery of low levels of microorganisms below the alert level during microbial monitoring or of pharmaceutical ingredient or finished product failure that is indicative of a loss of process control. (TR88)
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Aggregation
Clumping of proteins, viruses, or bacteria that may arise from several mechanisms and may be classified in numerous ways, including soluble/insoluble, covalent/noncovalent, reversible/irreversible, and native/denatured. (TR47)
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Air Removal Test
A test used to evaluate air removal and steam penetration in an empty sterilizer that is used for porous/hard goods load sterilization (e.g., Bowie-Dick Test, DART, Lantor Cube, Browns’ Test). (TR01) (TR 48)
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Airlock
A room that controls the airflow between two rooms of different classification. (TR 70)
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Aseptic Processing Simulation (APS)
A means for establishing the capability of an aseptic process as performed using a growth medium. (TR22) (TR62)
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Attribute
A physical, chemical, or microbiological property or characteristic of an input or output material. (TR60)
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Attributes (Process Performance Attribute)
An output variable or outcome that cannot be directly controlled, but is an indicator that the process performed as expected.(Synonym - Process Performance Parameter) (TR60)
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Attributes (Quality Attribute)
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)