
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 (3)
- TR 54-2: QRM: Packaging Labeling (3)
- TR 54-4: QRM: Biotech Drug Substance (2)
- TR 54-3: QRM: Drug Products (1)
- TR 58: Temp Controlled Distribution (1)
- TR 61: Steam in Place (1)
- TR 62: Manual Aseptic Processes (1)
- TR 65: Technology Transfer (1)
- TR 68: Drug Shortage Management (1)
- TR 69: Bioburden/Biofilm Management (1)
- TR 72: Passive Thermal Protection Systems: Qualification/Operations (1)
- TR 74: Reprocessing of Biopharmaceuticals (1)
- TR 13: Environmental Monitoring (1)
- TR 22: Aseptic Process Simulation (1)
- TR 26: Sterilizing Filtration of Liquids (1)
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Critical Area/Critical Zone
An area designed to maintain sterility of sterile materials. Sterilized product, containers, closures, and equipment may be exposed in critical areas. (TR13) (TR22) (TR44) (TR62)
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Endotoxin
Lipopolysaccharides from the cell walls of bacteria, the most potent of which derive from Gram-negative organisms. When injected, they are known to cause a febrile, or fever-producing reaction that can cause severe patient reactions, and on occasion, can be fatal. (TR26) (TR44) Pyrogenic lipopolysaccharide component of Gram-negative bacterial cell walls. (TR69)
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Failure
The condition or fact of not achieving expected results; a cessation of proper functioning or performance. (TR44)
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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)