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 57: Analytical Method Validation (3)
- TR 38: Manufacturing Chromatography Systems Postapproval Changes (ChromPAC) (3)
- TR 60: Process Validation (2)
- TR 64: Temp Controlled Systems Qualification (2)
- TR 14: Validation: Protein Purification Chromatography (2)
- TR 47: Virus Spikes/Virus Clearance (1)
- TR 48: Moist Heat Sterilizer Systems (1)
- TR 57-2: Analytical Method Development (1)
- TR 61: Steam in Place (1)
- TR 70: Cleaning/Disinfection Programs (1)
- TR 74: Reprocessing of Biopharmaceuticals (1)
- TR 76: Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging (1)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (1)
- TR 33: Rapid Micro Methods (1)
- TR 42: Validation: Protein Manufacturing (1)
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Identification
Use of an analytical procedure to determine the chemical and biochemical identity of a material. (TR57)
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Identity Test
A technique used to determine or confirm the identity of an organism (virus, bacteria, cells). (TR47)
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Impurity
Any component present in the drug substance or drug product that is not the desired product, a product-related substance, or excipient including buffer components. It may be either processor product-related. (TR14) (TR57) (TR74)
Any component present in the drug substance or drug product which is not the desired product, a product-related substance, or excipient. It may be either process- or product-related (17). (TR60)
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Impurity Profile
A description of the identified and unidentified impurities present in a drug substance (ICH A3A). (TR38)
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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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Inclusivity
The ability of an assay to detect a target microorganism. (TR33)
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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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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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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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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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Isolated Intermediate
An intermediate that is obtained as the product after workup of a purification step in the process scheme for the drug substance. The isolation or purification procedure should be part of the validated process. An aliquot of a product that is worked up and/or purified for purposes of characterization does not constitute an isolated intermediate. (TR38)