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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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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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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 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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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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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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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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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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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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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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Primary Pack

Packaging that protects the inoculated carrier from damage and contamination without preventing penetration of the sterilizing agent(s). (TR51)

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Primary Packaging Component

A component that is (or may be) in direct contact with the dosage form. Some examples of primary components are glass vials, syringe barrels, bottles, rubber closures, and container or closure liners. (TR39)

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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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Reefer Container

Refrigerated shipping container for transporting perishables, having its own stand-alone (selfpowered) cooling system. (TR54-2)

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Resistance Temperature Detector(s) (RTDs)

Resistance temperature detectors are temperature sensors in which the electrical resistance in the element increases with increases in temperature. This electrical resistance is then translated into a temperature value (expressed as a resistance versus temperature curve). (TR48)

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Shelf Life (also referred to as expiration dating period)

The time period during which a drug product is expected to remain within the approved shelf life specification, provided that it is stored under the conditions defined on the container label. (TR63)

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Temperature Controlled

The sequence of transportation events, from the manufacturer of the API up to the receipt of the final packaged product by the end user, which maintains temperature sensitive products within approved temperature specifications. Maintaining temperature control during these transportation events assures that product quality is maintained. (TR39)

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Temperature Profile

Anticipated ambient temperature variation and duration to which product may be exposed during transportation. (TR39)

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Temperature Sensitive Products

Products whose quality may be adversely affected by temperature extremes (e.g., frozen, refrigerated, and certain controlled room temperature products). (TR39)

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Temperature-Controlled Distribution

Material handling and movement of goods from an origin site to a receiving site, where the goods are kept within a specified temperature range using active and/or passive systems. (TR58)

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Temperature-Controlled Ocean Container

An actively cooled metal box, most commonly 20 or 40 foot long which can be easily transferred between different modes of transportation, such as ships, trains and trucks. Sometimes it is called a reefer container or intermodal container. (TR58)

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Temperature-Controlled Ocean Container (Reefer, Intermodal Container)

An actively cooled metal box (commonly 20 or 40 ft long) that can be easily transferred between different modes of transportation, such as between ships, trains, and trucks. (TR64)

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Temperature-Controlled Truck or Trailer

A cargo box attached to a truck chasse or as a trailer pulled by a truck that is equipped with a temperature control unit (TCU) to provide active cooling or heating control inside the box. Refrigerated trucks or trailers are sometimes referred to as “reefers”. The temperature control units are typically powered by an integrated engine or gen-set and not the engine that is used to propel the truck. (TR58) A cargo box attached to a truck chassis or consisting of a trailer pulled by a truck that is equipped with a TCU to provide active cooling or heating control inside the box (refrigerated trucks or trailers are sometimes referred to as “reefers”). (TR64)

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Tertiary Packaging Component

A component that is used to assemble secondary or primary packages in the form of the basic transportation unit and to provide protection against mechanical impact. Examples are corrugated cardboard boxes, but corresponding plastic boxes/containers are also used. (TR39)

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The Last Mile

This is a multidimensional cross-industry term that defines a point in the supply chain where the product or service directly faces the customer, end user or patient. (TR46)