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 (2)
- TR 58: Temp Controlled Distribution (2)
- TR 47: Virus Spikes/Virus Clearance (1)
- TR 55: TBA/TCA Detection Mitigation (1)
- TR 71: Emerging Methods for Virus Detection (1)
- TR 74: Reprocessing of Biopharmaceuticals (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 78: Particulate Matter in Oral Dosage Forms (1)
- TR 76: Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging (1)
- TR 33: Rapid Micro Methods (1)
- TR 43: Glass Defects (1)
Filter By Technical Report Keyword
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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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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Indicator Cells
Cell lines that are used in in vitro assays to detect the presence of viral agents. (TR71)
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Intraperitoneal (i.p.)
Term defines when a chemical is administered through the peritoneal cavity (area that contains the abdominal organs). (TR55)
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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)