
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 (10)
- TR 44: QRM: Aseptic Processes (8)
- TR 54: QRM:Manufacturing Operations (6)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (6)
- TR 64: Temp Controlled Systems Qualification (4)
- TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry (4)
- TR 46: Good Distribution: Last Mile (3)
- TR 67: Objectionable Microorganisms (3)
- TR 30: Parametric Release (3)
- TR 39: Cold Chain (3)
- TR 54-3: QRM: Drug Products (2)
- TR 54-4: QRM: Biotech Drug Substance (2)
- TR 68: Drug Shortage Management (2)
- TR 55: TBA/TCA Detection Mitigation (1)
- TR 57: Analytical Method Validation (1)
- TR 57-2: Analytical Method Development (1)
- TR 61: Steam in Place (1)
- TR 72: Passive Thermal Protection Systems: Qualification/Operations (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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Active Systems
Systems with active temperature control (e.g., air/sea freight containers, refrigerated trucks/cars). (TR39) System with active temperature control. It makes use of electricity or fuel for the compressor to maintain temperature. Examples include refrigerated trucks, temperature-controlled ocean containers, and active ULDs. (TR58) Actively powered system that uses electricity or other fuel source to maintain a temperaturecontrolled environment inside an insulated enclosure under thermostatic regulation (e.g., cold room, refrigerator, temperature-controlled truck, refrigerated ocean or air container). (TR64) (TR72) (Synonym: Active Temperature Controlled System)
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Active Unit Load Device (Active ULD)
A Unit Load Device (ULD) container used to consolidate cargo on aircraft that contains electrical or battery-powered temperature control systems for transporting temperature-sensitive materials; an RKN type is used in an FMEA example. (TR58) A unit load device with an active heating and/or cooling system that is typically used in air transportation, usually operated from externally supplied AC or DC power or from internal batteries. (TR64)
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Active Unit Load Device (ULD)
A Unit Load Device (ULD) container used to consolidate cargo on aircraft that contains electrical or battery-powered temperature control systems for transporting temperature-sensitive materials; an RKN type is used in an FMEA example. (TR58) A unit load device with an active heating and/or cooling system that is typically used in air transportation, usually operated from externally supplied AC or DC power or from internal batteries. (TR 64)
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CE Marking
The CE marking is a key indicator of a product’s compliance with EU legislation and enables the free movement of products within the European market. (TR58)
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Clinician
A physician, psychiatrist, etc., who specializes in clinical work as opposed to one engaged in laboratory or experimental studies. (TR58)
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Cold Chain
A temperature- and time-controlled supply chain for products (e.g., refrigerated products typically have a temperature storage range of 2 °C to 8 °C). (TR58)
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Controlled Room Temperature (CRT)
Defined by USP <1079> as the usual and customary working environment of 20 °C to 25 °C (68 - 77 F) that allows for deviations between 15 °C and 30 °C (59 - 86 F) based on stability data. (TR58)
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Deviation
Departure or digression from set parameters. (TR58)
Data or a result outside of the expected range or an unfulfilled requirement; it may be called nonconformity, defect, discrepancy, out-of-specification, out-of-limit, or adverse trend. (TR88)
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Distribution Testing
Qualification of packaging components for physical distribution integrity like shock, vibration, and drop tests. (TR58)
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Failure Effect
An impact on customer requirements. Generally, failure effect has an external customer focus, but it can also include downstream processes. (TR58)
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Hazard
The potential source of harm. (TR44) (TR54) (TR54-2) (TR58) (TR61)
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Incident
Any event that occurs during the shelf life of a product that may have an adverse effect on quality (e.g., temperature excursion, missing temperature monitor when required, shipment time in excess of qualified packout duration, wet/ crushed packaging). (TR58)
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Incident Management System
Part of the Quality Management System that handles incidents, deviations, excursions, and exceptions in the supply chain. (TR58)
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Incoterms
International commerce terms. These are a series of international sales terms, published by the International Chamber of Commerce (ICC), and widely used in international commercial transactions. (TR58)
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Mean Kinetic Temperature (MKT)
The single calculated temperature at which the total amount of degradation over a particular period is equal to the sum of the individual degradations that would occur at various temperatures. Thus, MKT may be considered as an isothermal storage temperature that simulates the nonisothermal effects of storage temperature variation. It is not a simple arithmetic mean. (TR46) (TR58)
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Packout
Insulated container that uses refrigerant to keep a product within a specified temperature and time range; see passive system. (TR58)
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Qualification
Documented testing that demonstrates with a high degree of assurance that a specific process will meet its pre-determined acceptance criteria. (TR39) (TR58) (TR64)
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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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Radio Frequency Identification (RFID)
Is an automatic technique for identifying objects using radio frequency transmissions. An RFID system generally consists of a tag, reader, antenna, and software. An RFID tag is simply another type of data carrier. Essentially, tags compromise a semiconductor chip with memory, processing capability and a transmitter connected to an antenna (aerial). (TR46) RFID is a method commonly used in retail of single directional data transfer from an identification tag (e.g., a data logger) to a stationary gateway or scanner; it is not to be confused with real-time monitoring. (TR58)
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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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Retailer
A “retailer” buys goods or products in large quantities from manufacturers or importers, either directly or through a wholesaler, and then sells smaller quantities to the end-user. Examples of retailers that sell pharmaceutical products are pharmacies and hospitals. (TR58)
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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 Assessment
A systematic process of organizing information to support a risk decision to be made within a risk management process. It consists of identification of hazards and the analysis and evaluation of risk associated with exposure to those hazards. (TR30) (TR44) (TR54) (TR58) (TR55) (TR67) (TR57-2) (TR54-5) (TR88)
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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 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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Shipper
An individual or company who tenders products for transportation. (TR39) The person or organization responsible for arranging transportation of goods with carriers and/or freight forwarders. (TR58)
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Shipping Lane
An established route of transportation between a specific point of origin to a specific destination. More defined routes will consistently use the same combination and types of transportation vehicles and transfer procedures, but this may not be observed through all shipping lanes throughout the last mile. (TR46) Lane described by origin, transportation node(s) and destination in combination with the used transport mode(s) (truck, aircraft, etc.). (TR58)