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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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TR 70: Cleaning/Disinfection Programs Quality Risk Management/QRM Sterile Processing Combination Products GMP/Good Manufacturing Processes/cGMP
Airlock
A room that controls the airflow between two rooms of different classification. (TR 70)

Source: TR 70: Cleaning/Disinfection Programs

Biotechnology Manufacturing Combination Products GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing

Adverse Trend
A series of alert-level or action-level excursions that indicates the system or areas are not in control and have the potential to affect the product quality. (TR 70) An increase in the frequency of alert- and action-level excursions or repeated recovery of low levels of microorganisms below the alert level during microbial monitoring or of pharmaceutical ingredient or finished product failure that is indicative of a loss of process control. (TR88)

Source: TR 70: Cleaning/Disinfection Programs

Virus Biotechnology Manufacturing Combination Products GMP/Good Manufacturing Processes/cGMP Inspections Quality Risk Management/QRM Sterile Processing