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 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations (4)
- TR 68: Drug Shortage Management (2)
- TR 43: Glass Defects (2)
- TR 51: Biological Indicators (1)
- TR 58: Temp Controlled Distribution (1)
- TR 86: Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing (1)
- TR 79: Particulate Matter Control in Difficult to Inspect Parenterals (1)
- TR 76: Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging (1)
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Data Integrity Controls
Controls put in place to either minimize the potential for a data integrity issue to occur or, if an issue does occur, the controls applied to increase the probability of detection.(TR84)
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Data Lake
A storage repository that holds, in a structured way, a vast amount of raw data, including metadata, in its native format until it is needed. (TR84)
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Data Process Flow Map
A flow map that uses a baseline process flow map and overlays the data flow. (TR84)
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Data Vulnerability
An indicator of data’s level of exposure to data integrity failures due to intrinsic weaknesses in manufacturing processes, data-capture technology, and human factors or a combination thereof.(TR84)
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Defect
(1) A departure of a quality characteristic from its intended level or state that occurs with a severity sufficient to cause an associated product or service not to satisfy its intended normal or foreseeable usage requirements. (TR51) (2) The nonfulfillment of intended usage requirements. The departure or absence of one or more quality characteristics from intended usage requirements. (TR43)
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Deterministic Leak Test Method
A method in which the leakage event being detected or measured is based on phenomena that follow a predictable chain of events. In addition, the measure of leak detection is based on physicochemical technologies that are readily controlled and monitored, yielding objective quantitative data. (TR86)
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Difficult-to-inspect Parenterals (DIP)
When the nature of the product or package limits the ability to perform a thorough inspection for particles. (TR79)
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Dimensional Product Quality
The product conforms to the required drawing dimensions. (TR43)(TR76)
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Distribution Testing
Qualification of packaging components for physical distribution integrity like shock, vibration, and drop tests. (TR58)
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Drug Shortage Prevention & Response Plan
A document that provides a structured action plan to proactively prevent drug shortages and also respond to a shortage in the event that one occurs. (TR68)
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Drug Shortage Risk Register
A single source of information on risks that can result in drug shortages, associated risk levels, risk control actions with owners, status, due dates and residual risk after appropriate risk control actions have been taken. (TR68)