
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 44: QRM: Aseptic Processes (7)
- TR 54-4: QRM: Biotech Drug Substance (6)
- TR 58: Temp Controlled Distribution (5)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (4)
- TR 54-3: QRM: Drug Products (3)
- TR 67: Objectionable Microorganisms (2)
- TR 68: Drug Shortage Management (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 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry (1)
- TR 30: Parametric Release (1)
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Decision Maker(s)
Person(s) with the competence and authority to make appropriate and timely quality risk management decisions.(TR54) (TR54-2)
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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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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)
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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 Acceptance
The decision to accept risk (ISO Guide 73). (TR54) (TR54-2) (TR58)
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Risk Analysis
The estimation of the risk associated with the identified hazards. (TR13) (TR30) (TR44) (TR54) (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 Management Report
Report that summarizes the outcomes of the QRM process. (TR54) (TR54-2) (TR54-5)
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Senior Management
Person(s) who direct and control a company or site at the highest levels with the authority and responsibility to mobilize resources within the company or site (TR54) (TR54-2)
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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)
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Stakeholder(s)
Any individual, group or organization that can affect, be affected by or perceive itself to be affected by a risk. Decision makers might also be stakeholders. For the purposes of this guideline, the primary stakeholders are the patient, health-care professional, regulatory authority, and industry (ICH Q9). (TR54) (TR54-2)
Any individual, group, or organization that can affect, be affected by, or perceive itself to be affected by a risk. Decision makers might also be stakeholders. (TR54-5)
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Trend
A statistical term referring to the direction or rate of change of a variable(s) (ICH Q9). (TR54) (TR54-2)