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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Fault Tree Analysis (FTA)
A deductive technique used to analyze the causes of faults (defects). The technique visually models how logical relationships between failures, human errors, and external events can combine to cause specific faults. (TR54) (TR54-2) (TR54-3) (TR54-5)

Source: TR 54: QRM:Manufacturing Operations

Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Inspections Validation Quality Risk Management/QRM

Decision Maker(s)
Person(s) with the competence and authority to make appropriate and timely quality risk management decisions.(TR54) (TR54-2)

Source: TR 54: QRM:Manufacturing Operations

Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Inspections Outsourcing Quality Risk Management/QRM Technology Transfer

Corrective Action and Preventative Action (CAPA)
Action to eliminate the cause of a detected nonconformity or other undesirable situation. NOTE: Corrective action is taken to prevent recurrence, whereas preventive action is taken to prevent occurrence. (TR 52) (TR 54-2) (TR 54-3) (TR 54-5) A subsystem used to collect and analyze information, identify and investigate product and quality problems, and take appropriate and effective measures to prevent recurrence of the identified problem (8). (TR88)

Source: TR 52: Supply Chain GDP

Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Inspections Validation Quality Risk Management/QRM