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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CGMP Record (FDA)
When generated to satisfy a CGMP requirement, all data become a CGMP record. You must document, or save, the data at the time of performance to create a record in compliance with CGMP requirements, including, but not limited to, §§ 211.100(b) and 211.160(a). FDA expects processes to be designed so that quality data is created and maintained and cannot be modified. (TR80)
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Complete Data (FDA)
FDA requires complete data in laboratory records, which includes raw data, graphs, charts, and spectra from laboratory instruments and associated metadata. (§§ 211.194(a) and 212.60(g)(3) (2). A complete record of all data secured in the course of each test, including date and time the test was conducted and all graphs, charts, and spectra from laboratory instrumentation, properly identified to show the specific component, drug product container, closure, in-process material, or drug product, and lot tested. (TR80)
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Corruption (Data) (FFIEC)
Errors in computer data that occur during writing, reading, storage, transmission, or processing, which introduce unintended changes to the original data.(TR80)