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.
(Please select "All" to restart a filtered Search)
Refine Results
Filter By Technical Report Number
Filter By Technical Report Keyword
Filter By Technical Report Category
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)