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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- TR 62: Manual Aseptic Processes (3)
- TR 22: Aseptic Process Simulation (3)
- TR 58: Temp Controlled Distribution (2)
- TR 60: Process Validation (2)
- TR 70: Cleaning/Disinfection Programs (2)
- TR 76: Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging (2)
- TR 42: Validation: Protein Manufacturing (2)
- TR 48: Moist Heat Sterilizer Systems (1)
- TR 52: Supply Chain GDP (1)
- TR 54: QRM:Manufacturing Operations (1)
- TR 57: Analytical Method Validation (1)
- TR 57-2: Analytical Method Development (1)
- TR 61: Steam in Place (1)
- TR 64: Temp Controlled Systems Qualification (1)
- TR 66: Single-Use Systems (1)
- TR 13: Environmental Monitoring (1)
- TR 14: Validation: Protein Purification Chromatography (1)
- TR 38: Manufacturing Chromatography Systems Postapproval Changes (ChromPAC) (1)
- TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers (1)
- TR 79: Particulate Matter Control in Difficult to Inspect Parenterals (1)
- TR 78: Particulate Matter in Oral Dosage Forms (1)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (1)
- TR 33: Rapid Micro Methods (1)
- TR 41: Virus Filtration (1)
- TR 43: Glass Defects (1)
- TR 44: QRM: Aseptic Processes (1)
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ISO/IEC
International Organization for Standardization/International Electrotechnical Commision. (TR52)
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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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In-Process Leachables
Chemicals substances that are leached, from product-contact or non-product-contact materials under typical process conditions and could be cleared or sufficiently diluted by downstream processes so as to be undetected as leachables in the final dosage. Alternate Terms: Transient Leachables, Migrant Leachable. (TR66)
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In-Process Method (In-Process Control)
Checks performed during production to monitor and, if appropriate, adjust the process to ensure that the intermediate or active pharmaceutical ingredient conforms to its specifications. (TR57-2)
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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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In-Use Testing (also called In-Situ Testing)
A field study that validates the effectiveness of a disinfecting agent, the trained operators, and the approved operating procedures. (TR70)
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Incident
Any event that occurs during the shelf life of a product that may have an adverse effect on quality (e.g., temperature excursion, missing temperature monitor when required, shipment time in excess of qualified packout duration, wet/ crushed packaging). (TR58)
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Incident Management System
Part of the Quality Management System that handles incidents, deviations, excursions, and exceptions in the supply chain. (TR58)
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Inclusivity
The ability of an assay to detect a target microorganism. (TR33)
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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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Independent Replicates
Two or more measurements or observations that are generated from independently prepared samples and do not affect each other. (TR57)
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Information-only Tests
Tests that provide data that are collected without pre-established acceptance criteria to further evaluate the process. (TR42)
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Installation Qualification (IQ)
Documented verification that the equipment or systems, as installed or modified, comply with the approved design, the manufacturer’s recommendations, and/or user requirements. (TR14) (TR42) (TR48) (TR61) (TR64)
The documented verification that the facilities, systems and equipment, as installed or modified, comply with the approved design and the manufacturer’s recommendations. (TR54-5)
Documented verification that the equipment or systems, as installed or modified, comply with the approved design, the manufacturer’s recommendations, and/or user requirements (17). (TR60)
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Intended Use/Intended Purpose
Use for which a product, process or service is intended according to the specifications, instructions and information provided by the manufacturer. (TR54)
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Intermediate (or In-Process Material)
A material produced during the steps of the processing of an API that undergo further molecular change or purification before it becomes an API. Intermediates may or may not be isolated. (TR60)
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Intermediate Material
The chemical mixture that may or may not have completed the chemistry steps, and thus is not in its final chemical and physical/conformational state, and has not been through final process steps to final drug substance. Examples in the small molecule world include isolated intermediates, intermediates, and final intermediates. Examples in the large molecule world include crude protein mixtures (pre-transformation, conversion, or folding) and purified protein prior to any final polishing steps. (TR38)
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Intervention
An aseptic manipulation or activity performed by personnel that occurs within the critical area. (TR22) (TR44) (TR62)
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Intervention, Corrective
An intervention that is performed to correct or adjust an aseptic process during its execution. Examples include such activities as: clearing component misfeed, adjusting sensors, and replacing equipment components. (TR22) (TR62)
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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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Irradiation
The process by which an item is exposed to ionizing radiation (typically gamma) to reduce or eliminate bioburden. (TR41)
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Isolates
Microorganisms that are recovered from a facility. (TR70)
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Isolator, Open
A decontaminated unit meeting ISO 5 conditions that provides uncompromised, continuous, isolation of its interior from the surrounding environment. It may transfer air directly to the surrounding environment through openings (e.g., “mouse holes”) that preclude the ingress of microbial contamination. (TR13) (TR22) (TR62)