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 (5)
- TR 54-3: QRM: Drug Products (3)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (3)
- TR 44: QRM: Aseptic Processes (3)
- TR 54-4: QRM: Biotech Drug Substance (2)
- TR 52: Supply Chain GDP (1)
- TR 58: Temp Controlled Distribution (1)
- TR 61: Steam in Place (1)
- TR 65: Technology Transfer (1)
- TR 68: Drug Shortage Management (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)
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Corrective Action and Preventative Action (CAPA)
Action to eliminate the cause of a detected nonconformity or other undesirable situation. NOTE: Corrective action is taken to prevent recurrence, whereas preventive action is taken to prevent occurrence. (TR 52) (TR 54-2) (TR 54-3) (TR 54-5)
A subsystem used to collect and analyze information, identify and investigate product and quality problems, and take appropriate and effective measures to prevent recurrence of the identified problem (8). (TR88)
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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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Facilitator
Independent QRM expert who facilitates risk assessment; guides documentation, risk control, and risk review; and helps present risk assessment results and risk control proposals. (TR54-2) (TR54-5)
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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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Hazardous Situation(s) [Cause(s
Circumstances in which people, property, or the environment is exposed to a hazard. (TR54-2)