Process Performance Qualification Protocol
A written plan preapproved by the quality unit that specifies critical steps, controls, and measurements. The process performance qualification protocol states how process performance qualification or other validation studies will be conducted, identifying sampling, assays, specific acceptance criteria, production equipment, and operating ranges. Results obtained for each study described in the protocol should be evaluated in an associated process validation report. (TR60)
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Process Performance Qualification Report
A report approved by the quality unit that summarizes specific tests performed, compares the test results with the protocol acceptance criteria, and addresses deviations encountered during the study. (TR60)
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Performance Indicator
An output variable or outcome that cannot be directly controlled but is an indicator that the process performed as expected. (TR60-3)
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Perimeter
Measured length of the outer edges of a particle.
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Probabilistic Leak Test Method
A method that is the converse of a deterministic leak test method, being stochastic in nature. Probabilistic tests rely on a series of sequential and/or simultaneous events, each associated with random outcomes described by probability distributions. (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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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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Process Performance Attribute (or Process Performance Parameter)
An output variable or outcome that cannot be directly controlled but is an indicator that the process performed as expected. (TR60-2)
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Product Characterization
The characterization of quality attributes, such as peptide map, glycosylation, chromatography profile, molecular weight, gel chromatogram, polymorphs, etc. (TR56)
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Pharmacodynamics
How the drug works in the body, the biochemical and physiological effects of drug and its mechanisms of their actions. (TR56)
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Pedigree
A statement of origin for a drug, active ingredient, or other critical starting material that identifies the original source of the material and each sale, purchase, or trade prior to receipt by the user, including the dates, names, and addresses of all parties involved in such transactions. Note: Also called a “batch tree.” (TR56)
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Pharmacokinetics
How the body processes the drug; the study of the movement of drugs in the body, including the processes of absorption, distribution, localization in tissues, biotransformation, and excretion. (TR56)
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Phase 3 Clinical Trials
Final clinical stage Phase 3 trials are designed to demonstrate the potential advantages of the new therapy; safety and efficacy of the new therapy are studied over a longer period of time, and more patients (1,000-3,000) are enrolled in the study with less restrictive eligibility criteria. Phase 3 studies are intended to help scientists identify rarer side effects of treatment and prepare for a broader application of the product. Phase 3 trials enroll patients to verify efficacy and monitor adverse reactions during long term use. (TR56)
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Phase 2 Clinical Trials
Once the initial safety of the study drug has been confirmed in Phase 1 trials, Phase 2 trials are performed on larger groups (20-300) and are designed to assess efficacy, as well as to continue safety assessments in a larger group of volunteers and patients. Phase 2a is specifically designed to assess dosing requirements (how much drug should be given). Phase 2b trials are specifically designed to study efficacy (how well the drug works at the prescribed dose(s). (TR56)
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Phase 1 Clinical Trials
Phase 1 trials are the first stage of testing in human subjects. Often, a small (20-100) group of healthy volunteers will be selected. For life-threatening indications such as oncology, these can be patients that have the target disease but may not yet be the ideal target population. This Phase includes trials designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug. These trials are often conducted in an inpatient clinic, where the subject can be observed by full-time staff. (TR56)
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Preliminary/Process 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. (TR54-5)
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Periodic Review
A documented review of pertinent data as appropriate (for example, manufacturing performance trend data, change history, deviation history) to confirm that a process/method/system continues to consistently produce a result meeting predetermined acceptance criteria. (TR54-5)
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Periodic Requalification
Re-execution of qualification studies performed on a periodic basis to verify that systems and processes remain able to produce a result that consistently meets predetermined acceptance criteria through execution of a lab or field study. (TR54-5)
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Probability of Detection
The likelihood of detecting a defective unit during an inspection process expressed as a probability, quantitatively as a number (0–1) or as a percentage (0–100%). (TR79)
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Powders
Powders are defined as a solid or a mixture of solids in a finely divided state intended for internal or external use. Powders used as pharmaceutical dosage forms may contain one or more APIs and can be mixed with water for oral administration or injection. (TR79)
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Particulate Matter
Particulate matter consists of mobile, randomly-sourced, extraneous substances, other than gas bubbles, that cannot be quantitated by chemical analysis due to the small amount of material that it represents and its heterogeneous composition. (TR79)
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Parison
The “tube” of polymer extruded by the BFS machine from which the containers are formed. (TR77)
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Particulate Load
The total quantity of particles in solution as tested per qualified method. (TR76)
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Particles/Particulate (Intrinsic Particles)
Particles that arise from sources related to the materials of construction of the component. Examples of intrinsic particle materials include elastomeric particles of the same formulation or ingredients from elastomer for elastomeric components. (TR76)
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Particles/Particulate (Inherent Particles)
Particles that are expected from the drug formulation, and therefore not included as a category in this Lexicon.(TR76)
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Particles/Particulate (Extrinsic Particles)
Particles that are not part of the formulation but are foreign and unexpected. Examples of extrinsic particles include fibers (e.g., cellulous), clothing fragments, hair, foreign rubber (including degraded/reverted rubber of the same formulation), metal, plastic, and paint. Materials such as foreign rubber, metal, and plastic are defined as extrinsic in cases where the specific material identified is not a material of construction and therefore not considered part of the rubber formulation.(TR76)
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Peak Intergration
Process used to by a chromatographic system to determine the peak area (based on height and width) and obtain the quantitation of the peak of interest. The measurement is based on the integral technique of splitting the peak into a large number of rectangles, which are then summed to provide an estimate of the total area under the peak. (TR80)
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Prefilled Syringe
A syringe that has been prefilled to contain a specific dose of medication. (TR73)
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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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Pressure
Force applied per unit area, usually expressed as psi, mbar, kPa or kg/cm2. (TR45) (TR26)
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Precision, Intermediate
The closeness of agreement between a series of measurements obtained within laboratory variations (e.g., different days, different analysts, different equipment). (TR57)
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Primary (Gold-Standard) Reference Standard
Substance shown by extensive analytical testing to be authentic, representative material; can be 1) obtained from an officially recognized source,2) prepared by independent synthesis, 3) obtained from existing production material, or 4) prepared by further purification of existing product material; is representative of the production process, so distinct reference materials for product-related substances, product-related impurities, and process-related impurities may need to be established. (TR57-2)
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Positive Unit
Unit filled in an aseptic processing simulation that exhibits detectable microbial growth after incubation. (TR22) (TR62)
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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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Process Characterization
Studies performed during process development to establish acceptable ranges for key input variables and critical operational parameters that define the process design space. (TR56)
A study that evaluates the process to increase process knowledge and examines proposed ranges and their individual and/or combined impact on target protein quality. Process characterization studies include deliberate variation of parameters to determine their effect on product quality attributes, often conducted as small-scale studies. (Also known as process evaluation studies, process justification studies, engineering studies, development studies, robustness studies, or process design studies. (TR60)
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Pressure Shock (Backward Pressure Shock)
Rapid backward fluid flow that may result in filter rupture. (TR45)
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Process Analytical Technology (PAT)
A system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality. (TR60) (TR60-2)
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Pressure Shock
An unanticipated rapid increase in fluid flow. [Synonym: Hydraulic Shock] (TR45)
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Precision, Repeatability
The closeness of agreement between a series of measurements obtained under ideal conditions (e.g., same day, analyst, and instrument). (TR57)
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Presterilization Bioburden
Number of viable organisms present on or in product prior to exposure to the sterilization process. (TR30)
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Precision
The degree of agreement among individual test results when the procedure is applied repeatedly to multiple samplings of the same suspension of microorganisms and using different suspensions across the range of the test. Also known as repeatability. (TR33)
The closeness of agreement (degree of scatter) between a series of measurements obtained from multiple sampling of the same homogeneous sample under the prescribed conditions. Precision may be considered at three levels: repeatability, intermediate precision, and reproducibility. It is usually expressed as the variance, standard deviation, or coefficient of variation of a series of measurements. (TR57)
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Process Characterization of Viral Clearance
Viral clearance studies in which nonspecific model viruses are used to assess the general virus clearance capacity of the manufacturing process to remove and/or inactivate viruses. (TR41)
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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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Process Evaluation Studies of Viral Clearance
Viral clearance studies in which relevant and/or specific “model” viruses are used to determine the ability of the manufacturing process to remove and/or inactivate these viruses. (TR41)
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Process Performance Qualification
Documented verification that a system is capable of consistently performing or controlling the activities of the processes it is required to perform or control, according to written and preapproved specifications, while operating in its specified operating environment. (TR01)
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Process Control Parameters
Conditions and corresponding measurements associated with the manufacturing process that may affect the identity, strength, quality, potency, and purity of a product. Examples of parameters of concern include bioburden, process rate, weight, volume, temperature, and pressure. (TR13)
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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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