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 54-2: QRM: Packaging Labeling (8)
- TR 54: QRM:Manufacturing Operations (4)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (4)
- TR 44: QRM: Aseptic Processes (3)
- TR 54-4: QRM: Biotech Drug Substance (2)
- TR 58: Temp Controlled Distribution (2)
- TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry (2)
- TR 52: Supply Chain GDP (1)
- TR 55: TBA/TCA Detection Mitigation (1)
- TR 57: Analytical Method Validation (1)
- TR 65: Technology Transfer (1)
- TR 67: Objectionable Microorganisms (1)
- TR 68: Drug Shortage Management (1)
- TR 72: Passive Thermal Protection Systems: Qualification/Operations (1)
- TR 74: Reprocessing of Biopharmaceuticals (1)
- TR 76: Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging (1)
- TR 43: Glass Defects (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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Detectability (D)
The ability to discover or determine the existence, presence, or fact of a hazard. (TR54-2) (TR54-3)
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Economically Motivated Adulteration
The fraudulent, intentional substitution or addition of a substance in a product for the purpose of increasing the apparent value of the product or reducing the cost of its production (i.e., for economic gain). (TR54-3)
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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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Hazard Analysis and Critical Control Points (HACCP)
A systematic, proactive, and preventative tool for assuring product quality, reliability, and safety (TR54-3) (TR54) A management system in which potential hazards are addressed through the identification and control of key risk factors (critical control points) of the biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. (TR55)
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Quality Risk Management (QRM)
A systematic process for the assessment, control, communication, and review of risk to the quality of the drug product across the product lifecycle.(TR43)(TR54-2)(TR54-3)(TR57)(TR67)(TR68)
Documentation to prove that an installation/ equipment/process is designed and/or tested according to predefined specifications. Documentation may include Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).(TR58)
A systematic process for the assessment, control, communication, and review of risks to the quality of the drug (medicinal) product across the product lifecycle.(TR 54-5)(TR 76)(TR88)
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Risk Priority Number (RPN)
A quantitative measure used when assessing the level of risk. (TR54-2) The product of severity (S), occurrence (O) and detection (D) used to determine the significance of the risk. (TR54-3)
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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)