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 (7)
- TR 58: Temp Controlled Distribution (7)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (5)
- TR 54-4: QRM: Biotech Drug Substance (4)
- TR 54-3: QRM: Drug Products (3)
- TR 67: Objectionable Microorganisms (2)
- TR 68: Drug Shortage Management (2)
- TR 30: Parametric Release (2)
- TR 55: TBA/TCA Detection Mitigation (1)
- TR 61: Steam in Place (1)
- TR 65: Technology Transfer (1)
- TR 72: Passive Thermal Protection Systems: Qualification/Operations (1)
- TR 74: Reprocessing of Biopharmaceuticals (1)
- TR 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations (1)
- TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry (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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Hazard
The potential source of harm. (TR44) (TR54) (TR54-2) (TR58) (TR61)
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Residual Risk
Risk remaining after risk control measures have been taken. (TR44) (TR58)
Risk remaining after risk control measures have been implemented (derived from ISO 14971:2007). (TR54) (TR54-2)
Risk remaining after risk control measures has been implemented. (TR54-5)
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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 Control
Items in place and/or actions to implement risk management decisions. (TR44)
Actions implementing risk management decisions. (TR54-2) (TR54-5) (TR84)
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Risk Evaluation
The comparison of the estimated risk to given risk criteria using a quantitative or qualitative scale to determine the significance of the risk (TR30) (TR54-2) (TR44) (TR58) (TR54-5)
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Risk Identification
The systematic use of information to identify potential sources of harm (hazards) referring to the risk question or problem description.(TR44) (TR54-2) (TR58) (TR54-5)
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Risk Management
The systematic application of quality management policies, procedures and practices to the tasks of assessing, controlling, communicating and reviewing risk. (TR44) (TR54) (TR54-2) (TR55) (TR67) (TR54-5)
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Risk Reduction
The process of decreasing the level of risk. (TR44)
Process for mitigation or avoidance of quality risk when it exceeds a specified (acceptable) level (e.g., reduce severity, probability of harm, and improves detectability of hazards and quality risks). (TR58)
Actions taken to lessen the probability of occurrence of harm and the severity of that harm. (TR54-2) (TR54-5)
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Risk Review
An ongoing monitoring of events, output and results of the risk management process that takes into account new knowledge and experience. [A] step in the risk management process for taking in account of new knowledge and experiences. (TR44) (TR58)
Review or monitoring of output/results of the risk management process considering (if appropriate) new knowledge and experience about the risk. (TR54-2) (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)