PDA Technical Glossary
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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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T Manufacturing Technology Transfer
Target Criteria
Numerical limits, ranges, or other suitable measures of target performance levels of an analytical method that indicate suitable performance for intended use. For a method entering qualification, this is a target performance criterion that, when assessed, indicates that the method is qualified for its intended purpose. (TR57-2)
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Target Product Profile (TPP)
A format for a summary of a drug development program described in terms of labeling concepts to facilitate communication regarding a particular drug development program. (TR60) (TR60-2)
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Test Article
Any food additive, color additive, drug, biologi­cally derived product, etc., for human use or any other article subject to regulation. “Test Article,” in this report’s context, referring to the samples used for toxicity and stability studies. (TR56)
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Transition Analysis
Mathematical evaluation of the chromatogram tracing as the mobile phase changes from one solution to another. An alternative to HETP and peak asymmetry for evaluating column packing and performance. (TR14)
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True Copy (FDA)
21 CFR 211.180(d) requires records to be retained "either as original records or true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records". Electronic copies can be used as true copies of paper or electronic records, provided the copies preserve the content and meaning of the original or raw data, which includes associated metadata and the static or dynamic nature of the original records.(TR80)(TR84)
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True Copy (MHRA)
A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure as the original.(TR80)(TR84)
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True Copy (WHO)
A true copy is a copy of an original recording of data that has been verified and certified to confirm it is an exact and complete copy that preserves the entire content and meaning of the original record including, in the case of electronic data, all essential metadata and the original record format as appropriate.(TR80)(TR84)
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