
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 58: Temp Controlled Distribution (13)
- TR 64: Temp Controlled Systems Qualification (13)
- TR 55: TBA/TCA Detection Mitigation (10)
- TR 39: Cold Chain (9)
- TR 68: Drug Shortage Management (8)
- TR 63: Clinical Trials Material Preparation (5)
- TR 46: Good Distribution: Last Mile (4)
- TR 48: Moist Heat Sterilizer Systems (2)
- TR 51: Biological Indicators (2)
- TR 54: QRM:Manufacturing Operations (2)
- TR 54-2: QRM: Packaging Labeling (2)
- TR 57: Analytical Method Validation (2)
- TR 67: Objectionable Microorganisms (2)
- TR 72: Passive Thermal Protection Systems: Qualification/Operations (2)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (2)
- TR 43: Glass Defects (2)
- TR 52: Supply Chain GDP (1)
- TR 53: Stability Testing New Drug Products (1)
- TR 54-3: QRM: Drug Products (1)
- TR 54-4: QRM: Biotech Drug Substance (1)
- TR 56: Phase Appropriate cGMP Application (1)
- TR 57-2: Analytical Method Development (1)
- TR 65: Technology Transfer (1)
- TR 3: Validation: Dry Heat (1)
- TR 26: Sterilizing Filtration of Liquids (1)
- TR 83: Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response (1)
- TR 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations (1)
- TR 76: Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging (1)
- TR 41: Virus Filtration (1)
- TR 45: Depth Filtration (1)
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- Manufacturing (61)
- Packaging Science (42)
- Validation (39)
- Outsourcing (21)
- GMP/Good Manufacturing Processes/cGMP (19)
- Biotechnology (18)
- Technology Transfer (16)
- Inspections (12)
- Microbiology (2)
- Visual Inspection (2)
- Combination Products (1)
- Filtration (1)
- Prefilled Syringes/PFS (1)
- Sterile Processing (1)
- Vaccines (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 Temperature Controlled System
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). (TR 72) (TR64)
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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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Ambient Temperature
The air temperature of an environment. (TR58)
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Ancillary Packaging Components/Systems
Additional means used in combination with the basic transportation unit to maintain the required temperature during transport. Examples include active systems and passive systems. (TR39)
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Attribute Sampling
Inspection where either the unit of product is classified as conforming or non-conforming or the number of non-conformities in the unit of products is counted with respect to a given requirement of set of requirements. (TR43)
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British Thermal Unit (BTU)
The amount of heat (measured in Joules) required to raise the temperature of one pound of
water by 1ºF.(TR64)
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Class I Recall
A situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. (TR55)
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Class II Recall
A situation in which use of or exposure to a violative product or may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequence is remote.(TR55)
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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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Cold Chain Tolerance Groups
This concept expands the “normal” definition of cold chain to include all products that need to be stored below 250C and also introduces the ancillary terms “ambient temperatures” and “controlled ambient”. (TR46)
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Commissioning
A well planned, documented and managed engineering approach to the start-up and transfer of facilities, systems and equipment to the end-user that results in a safe and functional environment that meets established design and user requirement specifications. Commissioning precedes Qualification and includes three phases:
1. Inspection, testing, and regulation
2. Adjustment and setting of work
3. Functional testing (TR 3)
A prescribed number of activities designed to take equipment and systems from a static, substantially complete state to an operable state. (TR 48)
A well planned, documented, managed engineering approach to the start-up and turnover of facilities, systems, and equipment to the end-user, that results in a safe and functional environment that meets established design requirements and stakeholder expectations.(TR 54) (TR 54-5)
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Comparative Transfer
Transfer of a method that involves the analysis of a predetermined number of samples of the same lot by both the sending and the receiving unit. (TR 57-2)
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Compatibility
Proof that no adverse interaction between the filter and the process fluid has occurred. (TR26) A term used in relation to the non-reactivity of filter materials with the substance to be filtered. (TR45)
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Compatibility (Filter)
The ability of a filter to be used with a particular process fluid without a change in the inherent properties of the filter. (TR41)
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Compendial Procedure
A method that is considered validated as published in one of the recognized compendia. (TR57)
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Complaint Files
(a) As defined by 21 CFR Part 211.198- Complaint Files. (b) A written record of each complaint shall be maintained in a file designated for drug product complaints. The file regarding such drug product complaints shall be maintained at the establishment where the drug product involved was manufactured, processed, or packed, or such file may be maintained at another facility if the written records in such files are readily available for inspection at that other facility. 1.The written record shall include the following information, where known: the name and strength of the drug product, lot number, name of complainant, nature of complaint, and reply to complainant .2.Where an investigation under 211.192 is conducted, the written record shall include the findings of the investigation and follow-up. The record or copy of the record of the investigation shall be maintained at the establishment where the investigation occurred in accordance with 211.180. (TR55)
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Condenser
Component that removes the heat absorbed by the refrigerant from the compressor and temperature- controlled area. (TR64)
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Controlled Environmental Space (CES)
An area that is controlled by regulating temperature. (TR64)
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Corked or Cork Taint
A musty-moldy off-flavor or taste imparted to the wine primarily due to the presence of 2, Combination Products 6-trichloroanisole (2, Combination Products 6-TCA) produced by the fungalo-methylation of 2, Combination Products 6-tricholorophenol (TCP) associated with corks, wooden barrels, and construction materials in wineries. (TR55)
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Critical Process (CP)
A process that impacts a critical quality attribute of the intermediate, drug substance or drug product being manufactured and therefore should have established critical process parameters that can be monitored or controlled to ensure that the process produces the desired quality.
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Date of Manufacture
For small molecules, the date of manufacture of a drug product is considered to be the initial date that an active ingredient has been added during manufacturing. For biologics the date of manufacture can be determined in multiple ways and should be consistent with internal quality systems and the product license application. (TR53)
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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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Drug Shortage Prevention & Response Plan
A document that provides a structured action plan to proactively prevent drug shortages and also respond to a shortage in the event that one occurs. (TR68)
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Drug Shortage Risk Register
A single source of information on risks that can result in drug shortages, associated risk levels, risk control actions with owners, status, due dates and residual risk after appropriate risk control actions have been taken. (TR68)
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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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Electronic Nose
An array of electronic sensors designed to selectively identify chemicals responsible for odors. The zNose™ system is one example that is commercially available and consists of a vapor pre-concentrator, a direct-heated high-speed chromatography column, a solid-state sensor and a programmable gate array microprocessor system. (TR55)
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Evaporator
Component that transfers heat out of or into the CES (to control the area temperature). (TR64)
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Extemporaneous Preparation (EP)
A type of compounding whereby a drug or combination of drugs and/or excipients is prepared under the supervision of a pharmacist to create a customized medication dosage form in accordance with a clinical protocol. (TR63)
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First Expiration, First Out (FeFo)
A method of controlling inventory to ensure that the material with the shortest remaining shelf-life is distributed first. (TR52)
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Full Loop Calibration
A calibration process that includes all measurement system components, from sensor to measurement value (e.g., temperature calibration of a data logger and attached thermocouple wires). (TR64)
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Fumigation of Wood Pallets
The currently approved International Standards for Phytosanitary Measures (ISPM) fumigation method is methyl bromide (MB) fumigation and is one of the two approved phytosanitary measures in ISPM 15 (treatment and marking of wood packaging materials [WPM] that is required for international shipment. The use of methyl bromide is not permitted in some IPPC countries (e.g. the EU), and the latest ISPM 15 standard has a recommendation to reduce its use. Note: Steam heat treatment is the other ISPM 15 approved method. (TR55)
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Generator Set (Genset)
A generator unit that is used to provide electrical power to maintain the temperature in a container/ trailer in transit and is not attached to a stationary power source. Gensets consist of a diesel or electrically powered engine that produces the required voltage to operate the temperature control unit (TCU; reefer) on the container/trailer. (TR64)
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Good Distribution Practices (GDPs)
Defined as that part of quality assurance that ensures that the quality of the pharmaceutical product is maintained by means of adequate control of numerous activities which occur during the distribution process. (TR55)
(commonly abbreviated GDP, or as GDocP to distinguish from “Good Distribution Practice”) Describes standards by which documents are created and maintained. (TR56)
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Heat-Treated Wood Pallets
Two types of methods to include kiln drying versus steam heat. (TR55)
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Incoming Inspection
A preventative program where parts or products are subjected to evaluation upon receipt.(TR43)
A program where, upon receipt, parts or products are subjected to measuring, examining, testing, or gauging one or more characteristics of a product or service, and comparing the results with specified requirements in order to establish whether conformity is achieved for each characteristic.(TR 76)
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Intermodal Container
A shipping container used to ship cargo through more than one of the four traditional modes of transportation (road, air, ocean, and rail). (TR64)
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Life Supporting or Life Sustaining Drug
Life supporting or life sustaining is used to describe a product that is essential to, or that yields information that is essential to, the restoration or continuation of a bodily function that is important to the continuation of human life. (TR68)
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Master Seed Stock
Reference culture of a microorganism derived from an authenticated source such as American Type Culture Collection (ATCC) and used to produce working seed lots. (TR51)
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Meaningful Disruption
A meaningful disruption is a change in production that is reasonably likely to lead to a reduction in the supply of a drug by a manufacturer that is more than negligible and affects the ability of the manufacturer to fill orders or meet expected demand for its product. A meaningful disruption is not an interruption in manufacturing due to matters such as routine maintenance and does not include insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short period of time. (TR68)
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Medically Necessary Drug
Any drug product used to diagnose, treat, or prevent a serious disease or medical condition for which no other drug is judged to be an appropriate substitute or there is an inadequate supply of an acceptable alternative as determined by the relevant health authority. (TR68)
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Method Comparability
The demonstration of analytical method comparability (AMC) for method replacements. A study to demonstrate that a modification to an existing method either improves or does not significantly change the analytical procedure’s characteristics relative to the methods’ validation and intended use. (TR57)
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Moisture Content of Wood
The moisture content of wood is calculated by the following formula: Moisture content = (Mg-Mod)/Mod. Where Mg is the green mass of the wood and Mod is its oven-dry mass (the attainment of constant mass generally after drying in an oven set at 103 ± 2 °C for 24h). The equation can also be expressed as a fraction of the mass of the water and the mass of the oven-dry wood rather than a percentage. For example, 0.59 kg/kg (oven-dry basis) expresses the same moisture content as 59% (oven-dry basis). (TR55)
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Over-the-Counter (OTC) Drug Products
Drug products sold in drug stores directly to customers without a physician’s prescription. (TR67)
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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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Pallets
Pallets are flat transportation structures that are used in the efficient shipping, warehousing and in-plant distribution of goods. A loaded pallet may be moved using a fork lift or pallet jack. They are usually 48 x 40 inches in dimension. They are most commonly constructed of wood but may be plastic, metal or even paper. (TR55)
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Passive System
Systems without active temperature control. Refrigerants may be, for example, gel packs, dry ice, water, and/or ice. Examples include insulated containers, packouts and cool boxes/containers. (TR58) Systems without active temperature control (e.g., insulated containers with or without refrigerants). (TR39)
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Planning Bill of Materials (BOM)
A complete list of the raw material (chemicals, media, powders, resin, etc.) and consumables/components (filters, bags, tubing, containers, etc.) that are required to manufacture the product. (TR65)