PDA Technical Glossary

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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    Displaying results 1 - 50 of 74
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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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Autoclave
Back Pressure
Residual pressure opposing the free flow of liquid or gas at the outlet side of the filter. (TR45) Pressure applied downstream of a filter or other piece of equipment. (TR26)
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Breakthrough Limited
A filtration operation resulting in a significant rise in filtrate turbidity accompanied by a small increase in differential pressure. This occurs when the adsorptive capacity of the filter is reached, resulting in the passage of particles smaller than the pore size of the filter that would normally be removed by adsorption. (TR45)
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Brevundimonas Diminuta (B. diminuta)
Small bacteria (0.3–0.4 &mum in diameter by 0.6–0.1 &mum long) used to challenge a sterilizing grade filter during validation testing. [Formerly Pseudomonas diminuta](TR45)
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Bulk Packaged Product
Consists of solid, liquid, or frozen product in a bulk container configuration such as a bag, tank, or drum. The product may be in these container configurations between process steps or prior to filling into vials, ampoules, cartridges, or syringes. (TR39)
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Changeover
The steps taken for switching multiproduct equipment from the manufacture of one product to the manufacture of a different product. (TR29) (TR49)
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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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Clean
Having product residues, process residues, and environmental contaminants removed to an acceptable level. (TR29) (TR49) The implementation of procedures to render an area, piece of equipment, system, or object free of adulterants and contaminants. (TR 70)
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Clean in Place (CIP)
The process of rinsing or washing of process components, as installed without removal, in order to remove or eliminate any contaminants. (TR45)
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Clean(liness)
The measurement for the level of particulates, microbes, or other extraneous substances on an item or surface. (TR 70)
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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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Comparability
The quality or state of being suitable for comparison. FDA may determine that two products are comparable if the results of the comparability testing demonstrate that a manufacturing change does not affect identity, strength, quality, purity, or potency as they may relate to the safety or effectiveness of the product. (TR38)
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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
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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Concentration Factor
Consumables
This refers to items (e.g., SUS, storage bags, tubing, filters, diaphragms, flasks, etc.) that form or are a part of process equipment and are used on a per batch basis. (TR66)
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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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Emissivity (?)
The emissivity of the surface of a material is its effectiveness in emitting energy as thermal radiation. This is measured between 0 (zero) and 1 (one); 0 having the ability to reflect all energy, and 1 allowing all energy to pass through it. Glass, for example, has emissivity of 0.91 (smooth, uncoated); aluminium foil has emissivity of 0.03. (TR72)
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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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ISTA: International Safe Transit Association
World-wide organization that supports its membership in designing and developing effective pre-shipment packaging performance standards, guides, and best practices for product distribution. (TR39)
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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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Kiln Drying (Wood Pallets)
A process of drying lumber in a dry kiln to a specified moisture content using the correct drying schedule (combination of dry- and wet-bulb temperature settings). Kiln-drying suffices as a heat treatment. This type of treatment is not ISPM certified and would not necessarily have an HT (heat-treated) stamp. However, this is a normal process for drying of lumber. (TR55)
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Logistics Service Providers (ISP or 3PIs)
Freight forwarders and brokers that assist in moving the product, but may not physically touch the product. (TR52)
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Manufacturing
The production, packing, testing, storage, release and distribution of drugs or medical devices for use in humans or animals where the manufacturing is indented to produce doses, typically in significant numbers, for an undefined population of future patients or clinical trial subjects. (TR63) All operations including purchasing and receipt of materials to production, packaging, labelling, quality control, release, storage, distribution of components and the related controls. (TR 76)
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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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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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Microprocessor
One of the five major components of a TCU, the unit interfaces with temperature sensors in the discharge and return air and adjusts the output rate of active cooling or heating to achieve the setpoint temperature. (TR64)
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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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Organohalogens
The major organohalogens or organic compounds containing chlorine, bromine or iodine of interest are halophenols and haloanisoles, especially 2,4,6 tricholorophenol (TCP), 2, 4, 6 tribromophenols (TBPs), 2, 4, 6 trichloroanisole (TCA), and 2, 4, 6 tribromoanisole (TBA). (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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Peltier Device
Peltier devices are small, solid-state ceramic and doped-semiconductor sandwiches designed to function in small cooling and heating applications. The devices can be “stacked” for greater cooling/heating but do draw considerable power. The advantage of these devices is that there are no moving parts, no maintenance, no refrigerant gasses, no noise, and no vibration. Disadvantages may include: high cost, fragility, and scalability, in addition to the aforementioned high power draw. (TR46)
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Phase Change Material (PCM)
A physical material that stores and releases thermal energy when freezing or melting. A PCM releases energy when freezing [latent heat energy] and absorbs energy when melting. (TR46)
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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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