
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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Component, Primary
Element of the assembled prefilled syringe (needle, plunger stopper and tip closure, or adhesive) directly in contact with the drug. (TR 73)
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Component, Secondary
Element of the assembled prefilled syringe (plunger rod, backstop, or safety system) that interacts with the primary components and provides functionality to the delivery system. (TR 73)
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Formative Usability Evaluation
Observed actual or simulated use of early prototypes to help reliably identify product conceptspecific, use-related hazards that may have been missed by other methods. (TR73)
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Summative/Validation Testing
Evaluative testing providing evidence to show that representative users in the expected use conditions can perform all essential and critical tasks required for safe and effective use of the device. (TR73)
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Use-related Risk Analysis
A systematic assessment of all of the user steps involved in using the device with particular consideration of the potential use errors, their associated clinical consequences along with the risk-mitigation strategies, and the method of validating the risk-mitigation strategies. (TR73)