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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Critical Process (CP)
A process that impacts a critical quality attribute of the intermediate, drug substance or drug product being manufactured and therefore should have established critical process parameters that can be monitored or controlled to ensure that the process produces the desired quality.
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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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Historian
A type of database designed to archive automation and process data. (TR84)
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Peer Review
A review of data by a colleague who has a similar level of responsibilities as the person performing the activity or capturing the data. (TR84)
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Quality Unit
An independent quality unit/structure with authority to fulfill certain pharmaceutical quality system responsibilities (7). (TR84)
An organizational element within a pharmaceutical company with the authority and responsibility for quality as defined by 21 CFR 211.22 (11). The quality control unit typically comprises the quality control and quality assurance functions. (TR88)