Pre-Filter
Any filter placed upstream of the final filter. (TR26)
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Process Flow Diagram (PFD)
A document, typically prepared by R&D, that describes the intended manufacturing process. The PFD includes all relevant information for the operation of the manufacturing process, organized by unit operation. The PFD serves as the source document for the initial development of the master production records and is locked down once development has determined that the process can be controlled. (TR65)
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Process Characterization Report
A report that includes results from a study characterizing the performance of a unit operation and/or operations conducted in a process characterization study. The report describes process characteristics, the operational parameters (e.g., critical, key, and non-key) and their acceptable ranges (limits), and acceptance criteria for Validation
protocols. (TR14) (TR42)
A report that includes results from a process characterization study with information on the performance of one or several unit operation(s). The report describes process characteristics, the parameters (e.g., critical or noncritical) and their studied ranges (limits) and may outline acceptance criteria for process performance qualification protocols.(TR60)
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Post-fill Inspection
Inspection of glass containers after product filling. (TR43)
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Probability of a Non-Sterile Unit (PNSU)
The number that expresses the probability of occurrence of a non-sterile unit after exposure to a sterilization process. Within the pharmaceutical industry, a design end point better than or equal to the probability of one non-sterile unit in a million units is expected, i.e., PNSU ≤ 10–6. [Synonym: Steriliy Assurance Level (SAL)] (TR01)
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Process Parameter (PP)
A process variable, process value or process parameter is the current status of a process under control. An example of this would be the temperature of a furnace. (TR54-4)
An input variable or condition of the manufacturing process that can be directly controlled in the process. Typically, these parameters are physical or chemical (e.g., temperature, process time, column flow rate, column wash volume, reagent concentration, or buffer pH). (TR60-3)
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Prefillable
Syringes and associated components considered as starting material for the filling and assembling process of a prefilled syringe. (TR73
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Primary Contact Surfaces
All process surfaces that have a direct influence on the quality of the drug substance being manufactured, including surfaces processing equipment, storage containers, and of processing aids during manufacturing operations. (TR54-4)
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Potential Drug Shortage
A potential drug shortage is described as the occurrence of internal or external situations (single or in a combination of both), which could result in an interruption of supplies of a medicinal product, if not properly addressed and controlled. (TR68)
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Primer
A short synthetic single-stranded nucleic acid complementary to a specific sequence of a target gene, DNA or RNA. It usually serves to initiate the de novo synthesis of nucleic acid from a template. (TR50)
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Preparation Site
The location where extemporaneous preparations of Clinical Trial Materials (CTM) are made. (TR63)
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Preliminary Hazard Analysis (PHA)
A tool of analysis based on applying prior experience or knowledge of a hazard or failure to identify future hazards, hazardous situations and events that might cause harm, as well as to estimate their probability of occurrence for a given activity, facility, product or system (ICH Q9). (TR54) (TR54-2) (TR54-3) (TR54-4)
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Process
A series of operations and/or actions used to produce a desired result. (TR38)
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Pre-Vacuum Process
A sterilization process in which air is removed from the chamber using a vacuum pump or other mechanical system before the exposure phase begins. This method is particularly suited to load items that can trap air such as tubing, filters and filling machine assemblies. (TR01) A process in which air is removed by applying a vacuum (i.e., negative pressure) or pulses of vacuum to precondition the system prior to the exposure phase. (TR61)
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Preventative Action
Action to eliminate the cause of a potential non-conformity or other undesirable potential situation. NOTE: Preventative action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence. (TR54)
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Pressure Shock (Forward Pressure Shock)
Rapid increase in forward fluid flow that may dislodge particulates. (TR45)
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Preparation Record
An approved document that gives the detailed instructions for preparation of the Clinical Trial Materials (CTM). (TR63)
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Precision, Reproducibility
The closeness of agreement between a series of measurements for the same sample obtained among different laboratories. (TR57)
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Potency
The measure of the biological activity using a suitably quantitative biological assay, based on the attribute of the product that is linked to the relevant biological properties. (TR57)
An expression of the activity of a secondary calibration standard to relate units of weight (ng/ vial or ng/mL) to units of activity (EU/ng) in a preparation.(TR82)
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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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Practice of Pharmacy
The interpretation, evaluation and implementation of medical orders which may include the administering, preparing, compounding, preserving, and/or the dispensing of drugs, medicines and therapeutic devices on the basis of prescriptions, clinical protocol or other legal authority. Note: Many localities have broader definitions describing very specific activities and responsibilities that further defines the practice of pharmacy. (TR63)
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Prefilled
Syringe assembly after being filled with pharmaceutical product and being closed. (TR73)
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Process Performance Qualification (PPQ)
The second element of the Process Qualification. It includes a combination of the actual facility, utilities, equipment, and the trained personnel with the commercial manufacturing process, control procedures, and components to produce commercial batches. A successful PPQ will confirm the process design and demonstrate that the commercial manufacturing process performs as expected. Batches prepared are also called Conformance batches or PPQ batches. (TR60) (TR54-5)
Confirming that the manufacturing process, as designed, is capable of reproducible commercial manufacturing. (TR60-2)
The second stage of process qualification. It includes a combination of the actual facility, utilities, equipment, and trained personnel and the commercial manufacturing process, control procedures, and components to produce commercial batches. A successful PPQ will confirm the process design and demonstrate that the commercial manufacturing process performs as expected. Batches prepared are also called conformance batches or PPQ batches. (TR60-3)
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Wash
Step in a chromatography cycle designed to flush the column to remove substances acquired during a previous step (often used between the load and elution steps). (TR14)
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Virus Seed
An initial virus stock produced after a new virus is introduced into a laboratory. Its purpose is to create a Master Virus Bank. (MVB) (TR47)
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Volatile
Evaporates easily; converts easily from a liquid form to gas. (TR45) (TR26)
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Virus Production Lot
A virus preparation that is used directly in a clearance study. It can be crude or purified. Typically a large volume is produced, tested and qualified. This volume is divided into multiple aliquots for individual clearance studies. (TR47)
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Virus (Specific Model Virus)
Virus that is closely related to the known or suspected virus (same genus or family), having similar physical and chemical properties as those of the observed or suspected virus. (TR47)
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Volumetric Throughput (Vmax)
The maximum volume that can be processed through a filter area. It is the volumetric capacity of the filter for a given process fluid and generally expressed in L/m2. (TR41) (TR47)
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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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Warning Letters
Type of correspondence that notifies a regulated industry about violations that FDA has documented during its inspections or investigations. (TR67)
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Virus Removal
Physical separation of virus particles from the intended product. (TR41)
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Virus Preparation
According to the mode of preparation the following terms are used: Crude Virus Preparation: A virus preparation that has undergone minimal processing post propagation. The virus is usually separated from cells which are lysed as the result of virus replication or are freezed/thawed in one or several cycles to release the virus from infected cells. The preparation is typically purified from cell debris by low speed centrifugation. Purified Virus Preparation: A virus that has undergone purification process by one or more techniques, such as density ultracentrifugation, chromatography or membrane adsorber. The purity of the virus preparation varies depending on the purification technique and should be characterized by appropriate analytical methods. (TR47)
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Void Volume
See Porosity. (TR45)
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Water for Injection (WFI)
Water purified by distillation or a purification process that is equivalent or superior to distillation in the removal of chemicals and microorganisms and contains no added substances. (TR45)
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Visually Clean
Absence of materials that would adulterate a product when inspected with the eyes. (TR70)
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Work Breakdown Structure (WBS)
A hierarchical and incremental decomposition of a project into phases, deliverables, and work packages; commonly a tree structure that shows a subdivision of effort required to achieve an objective. (TR65)
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Viscosity
A solution property that is a measure of the fluid’s resistance to deformation when acted upon by shear forces. (TR15)
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Water for Bacterial Endotoxin Test (BET)
Sterile Water for Injection or other water that shows no reaction with the specific bacterial endotoxin test reagent with which it is to be used, at the limit of sensitivity of such reagent. (TR3)
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Worst-Case Conditions
A set of conditions encompassing upper and lower processing limits and circumstances, including those within standard operating procedures, which pose the greatest chance of process or product failure when compared to ideal conditions. Such conditions do not necessarily induce product or process failure. (TR28)
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Worst-Case Process Condition
A condition or set of conditions encompassing upper and/or lower processing limits and circumstances, within standard operating procedures, which pose the greatest chance of product or process failure when compared to ideal conditions (such conditions do not necessarily induce product or process failure). (TR29)
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Z-Value
The number of degrees of temperature change necessary to change the D-value by a factor of 10. The z-value allows integration of the lethal effects of heat as the temperature changes during the heating and cooling phases of a sterilization cycle. (TR01) (TR3) The number of degrees of temperature change necessary to change the D-value by a factor of 10. The z-value allows integration of the lethal effects of heat over time (i.e., calculation of F0) as the temperature changes in a cycle. (TR61)
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Worst Case Soil
A soil that is the most difficult to clean from production equipment based on knowledge generated from laboratory studies, scientific properties, and/or production experience. (TR29)
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Working Cell Bank (WCB)/Working Virus Bank (WVB)
A stock of cells or virus derived from the MCB/MVB and used to produce production cells, assay cells or virus production lots. (TR 47)
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Working Seed Lot
A seed lot generated from the master seed stock by a single passage. (TR51)
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Yield, Theoretical
The quantity that would be produced at any appropriate phase of production, based upon the quantity of material to be used, in the absence of any loss or error in actual production. (TR45)
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Worst Case
A set of conditions encompassing upper and lower processing limits and circumstances, including those within standard operating procedures, that pose the greatest chance of process or product failure (when compared to ideal conditions). Such conditions do not necessarily induce product or process failure. (TR60)
A set of conditions encompassing upper and lower processing limits and circumstances, including those within standard operating procedures, that pose the greatest chance of process or product failure (when compared to ideal conditions). Such conditions do not necessarily induce product or process failure. (TR62) (TR60-2)
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Worst Case Load
The load configuration that is determined to be most difficult to sterilize. This is a function of the cycle control strategy and load item characteristics (e.g., mass, configuration, or air removal challenges). For porous/hard goods loads, this may not necessarily be the minimum or maximum load. (TR01) The load configuration that is determined to be most difficult to sterilize or depyrogenate. This is a function of the process control strategy and load item characteristics (e.g., mass, configuration). (TR3)
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Yield, Expected
The quantity of material or the percentage of theoretical yield anticipated at any appropriate phase of production based on previous laboratory, pilot scale or manufacturing data. (TR45)
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Temperature Control Unit (TCU)
A unit that controls the refrigeration and heating systems. It typically contains a microprocessor and thermostat to maintain the set temperature. (TR64)
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