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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Qualified Person (QP)
An individual as defined in the European Union pharmaceutical regulation as described in Directive 2001/83/EC that has the legal responsibility for batch release of medicinal products.
Note: See also EU GMP Annex 16, Certification by a Qualified Person and Batch Release. (TR56)