PDA Technical Glossary

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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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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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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Test Sets
A group of defect standards combined with good or blank units used to evaluate the probability of detection in visual inspection or testing system performance. Test sets can be used for inspec­tor training, validation of automated systems, or other special studies as needed. (TR79)
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Visible Particle Range
Particulate matter sized above the visible particle 70% probability of detection threshold are con­sidered in the visible range, typically >100-150 μm. (TR79)
Source:
“As Marketed”
Term used to describe the state or appearance of the product during 100% or AQL visual in­spection (prior to labeling). As marketed refers to the product in-situ or the form in which it is distributed, for example clear liquid, lyophilized, powder, opalescent liquid, etc. (TR79)
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