Container Closure System (CCS)
The sum of packaging components (primary and secondary) and materials that together contain and protect a product.(TR86)
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Shape factor (SF)/Circularity
Provides information on the roundness of a particle. The SF value is between 0 and 1, where 1, represents a circle. A is the area of the particle and p is the perimeter. (TR85)
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Aspect Ratio
The length of a particle or fiber divided by its width. (TR85)
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Deterministic Leak Test Method
A method in which the leakage event being detected or measured is based on phenomena that follow a predictable chain of events. In addition, the measure of leak detection is based on physicochemical technologies that are readily controlled and monitored, yielding objective quantitative data. (TR86)
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Labeling
The process by which a label is affixed to a packaging component. (TR85)
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Container Closure Integrity Test (CCIT)
A package leak test (either physicochemical or microbiological) that detects the presence of a package breach or gap. Some tests may also be able to identify the magnitude and/or location of the leak (the term container closure integrity test is synonymous with package leak test or package integrity test for the purposes of this TR). (TR86)
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Maximum Allowable Leak Limit (MALL)
The greatest gap or leak rate that does not put product quality at risk (2). (TR86)
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Package integrity
Is the measure of the ability of the package to prevent product loss or maintain product sterility and the ability to maintain the internal environment (2). (TR86)
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Sterile/Microbial Barrier
The purported location on a container closure system beyond which no microorganism can pass under conditions qualified for the barrier. (TR86)
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Data Lake
A storage repository that holds, in a structured way, a vast amount of raw data, including metadata, in its native format until it is needed. (TR84)
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Data Integrity Controls
Controls put in place to either minimize the potential for a data integrity issue to occur or, if an issue does occur, the controls applied to increase the probability of detection.(TR84)
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Data Vulnerability
An indicator of data’s level of exposure to data integrity failures due to intrinsic weaknesses in manufacturing processes, data-capture technology, and human factors or a combination thereof.(TR84)
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Data Process Flow Map
A flow map that uses a baseline process flow map and overlays the data flow. (TR84)
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Quality Unit
An independent quality unit/structure with authority to fulfill certain pharmaceutical quality system responsibilities (7). (TR84)
An organizational element within a pharmaceutical company with the authority and responsibility for quality as defined by 21 CFR 211.22 (11). The quality control unit typically comprises the quality control and quality assurance functions. (TR88)
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Historian
A type of database designed to archive automation and process data. (TR84)
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Peer Review
A review of data by a colleague who has a similar level of responsibilities as the person performing the activity or capturing the data. (TR84)
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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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Visible Particle Range
Particulate matter sized above the visible particle 70% probability of detection threshold are considered in the visible range, typically >100-150 μm. (TR79)
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Test Sets
A group of defect standards combined with good or blank units used to evaluate the probability of detection in visual inspection or testing system performance. Test sets can be used for inspector training, validation of automated systems, or other special studies as needed. (TR79)
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Implants
Implants are long-acting dosage forms that provide continuous release of an API for periods of months to years. They are administered by the parenteral route. For systemic delivery, they may be placed subcutaneously or, for local delivery, they can be placed in a specific region in the body. (TR79)
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Difficult-to-inspect Parenterals (DIP)
When the nature of the product or package limits the ability to perform a thorough inspection for particles. (TR79)
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“As Marketed”
Term used to describe the state or appearance of the product during 100% or AQL visual inspection (prior to labeling). As marketed refers to the product in-situ or the form in which it is distributed, for example clear liquid, lyophilized, powder, opalescent liquid, etc. (TR79)
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Technically Unavoidable Particles (TUPs)
Particles that are visibly different from the bulk of the material when viewed with the naked eye within the container or against a suitable background (e.g., size, shape, color, number, texture) and are inherent to the manufacturer’s process, product, or raw materials. The unintended presence of a small quantity of particles, stemming from impurities of natural or synthetic ingredients, the manufacturing process, storage, or migration from packaging that is technically unavoidable in good manufacturing practice, and do not pose a risk to patient safety. (TR78)
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Intrinsic Particles
Those particles that arise from sources related to the formulation, packaging, or assembly processes. In each of these cases, the particle material (e.g., glass, stainless steel, rubber, or gasket material) could be identified as a known product-contact material. (TR78)
A particle that comes from within the primary process. These are qualified product contact materials and are often associated with the primary packaging components. They are unplanned but not unexpected.(TR85)
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Sampling Plan True AQL
The quality of product for which the percent of lots expected to be accepted (Pa) is 95.0. These values are found in Tables X-A-1 to X-R-1 in ANSI/ASQ Z1.4.(TR76)
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In-Process Observations
Observations or findings that are found during the processing of a product or products.(TR76)
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Container Closure Integrity (CCI)
The ability of a package to prevent product loss, to block microorganism ingress, and to limit entry of detrimental gases or other substances, thus ensuring that the product meets all necessary safety and quality standards.(TR76)
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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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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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Pressure Decay Test
A leak test in which a container or system is pressurized with air to a preset level. After the pressure has stabilized, the decay in pressure over a preset test time is measured and evaluated to determine if a leak (defect) is present. (TR66)
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Pressure Hold Test (or Leak Test)
A test for leaks and gross defects in which the system is held at a defined pressure for a defined time. Failure is indicated by the observation of a steady stream of air bubbles downstream of the filter. (TR41)
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Water Activity (Aw)
Water Activity, Aw is the ratio of the vapor pressure of water in a product (P) to the vapor pressure of water in a product (P) to the vapor pressure of pure water (Po) at the same temperature. It is numerically equal to 1/100 of the RH generated by the product in a closed system. It is a measure of the free or available moisture in the material. Note: Water activity ≠ water content. RH can be calculated from direct measurements partial vapor pressure or dew point, or from indirect measurements by sensors whose physical or electric characteristics are altered by the RH to which they are exposed. Microorganisms need available water within a pharmaceutical product, as well as nutrients and minerals, to proliferate. Water activity, and not water content, is a better measure of the free water, in contrast to bound water that microbial cells require for metabolic activity and osmotic regulation. Effects of reduced Aw on microbial growth include a longer lag phase, slower growth rate, lower numbers of organisms in the stationary phase, and reduced microbial toxin production; below a specified Aw for an organism, microbial growth will not occur. (TR55) (TR67)
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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-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 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 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 Profile
Anticipated ambient temperature variation and duration to which product may be exposed during transportation. (TR39)
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Thumb Pad
Disk at end of plunger rod. (TR73)
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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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Thermal Mass
The mass of material present multiplied by that material’s specific heat capacity. (TR64)
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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)
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Slip Sheest
Plastic sheets often made of polyethylene and sometimes used in distribution/transportation warehouse and shipping systems to separate pallet loads of product. Slip sheets may be important due to the ability of polyethylene to concentrate TBA in proximity to product. (TR55)
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Stringer Pallet
A pallet that uses a frame of three or four parallel pieces of lumber (called stringers). The top decks are affixed to the stringers to create the pallet structure. (TR55)
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Steribag
Sealing bag made at least partly of steam-permeable material to wrap and seal containers for sterilization (e.g., tub-nest configurations). (TR73)
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Storage Temperature
The temperature range listed on the medicinal product label specified for long term storage. (TR39)
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Store
A store is a temperature-controlled and / or temperature- monitored warehouse, chamber, or cabinet where pharmaceutical products are stored. (TR58)
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Stringer
A continuous, longitudinal, solid or notched beam-component of a pallet used to support deck components, often identified by location as the outside or center stringer. (TR55)
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Ready-To-Use
A marketing term often used to describe the benefits of single-use technology or SUS. This designation has no regulatory or scientific basis supporting suitability for use and the end user is responsible to evaluate and determine if appropriate quality requirements are met for their application. (TR66)
Washed and sterilized components supplied in a package suitable for transfer into an aseptic processing area and used with sterile injectable products without further processing. (TR85)
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