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 54: QRM:Manufacturing Operations (4)
- TR 54-2: QRM: Packaging Labeling (4)
- TR 54-3: QRM: Drug Products (2)
- TR 68: Drug Shortage Management (2)
- TR 58: Temp Controlled Distribution (1)
- TR 65: Technology Transfer (1)
- TR 67: Objectionable Microorganisms (1)
- TR 72: Passive Thermal Protection Systems: Qualification/Operations (1)
- TR 74: Reprocessing of Biopharmaceuticals (1)
- TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry (1)
- TR 30: Parametric Release (1)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (1)
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Failure Mode and Effects Analysis (FMEA)
A method of assessing and evaluating risk. (TR44)
A systematic method for identifying, analyzing, prioritizing and documenting potential failure modes, their effects on system, product and process performance, and the possible causes of failure in order to prevent defects from occurring. (TR54) (TR54-2) (TR54-3) (TR54-4) (TR74) (TR54-5)
A tool for analyzing processes or systems to evaluate all operating steps in order to identify and assess the risk associated with any potential failures. (TR65)
An analytical technique that results in a rankordered list of concerns to take action on. (TR72)
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Harm
Damage to health, including damage occurring from loss of product quality or availability. (TR44) (TR54) (TR54-2) (TR54-4) (TR68)
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Risk
The combination of the probability of occurrence of harm and the severity of that harm.(TR30) (TR44) (TR54) (TR54-2) (TR54-4) (TR58) (TR67) (TR68) (TR88)
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Risk Prioritization Number (RPN)
A quantitative method for determining the level of risk by multiplying the severity, occurrence and detectability rankings of the failure or event. (TR44)
The Risk Priority Number, or RPN, is a numeric assessment of risk assigned to a process, or steps in a process, as part of Failure Modes and Effects Analysis (FMEA), in which a team assigns each failure mode a numeric values that quantifies likelihood of occurrence, likelihood of detection, and severity of impact. (TR54-4)
A quantitative measure used when assessing the level of risk. (TR54-5)
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Severity (S)
A measure of the possible consequences of a hazard. (TR44) (TR54) (TR54-2) (TR54-3)(TR54-4) (TR54-5)