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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 52: Supply Chain GDP

Transportation Service Providers (TSP)

Companies that physically transport the product. (TR52)

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Root Cause Analysis (RCA)

An evaluation conducted for the purpose of identifying the cause of the deviation or non-conformance. (TR52)

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Process Validation Master Plan (PVMP)

A document that defines the process validation scope and rationale and that contains the list of process validation studies to be performed (Synonym: Validation Master Plan). (TR42) (TR60) The plan that documents rationale for the approach to validation and lists all systems and their validation status. (Note: The VMP can be used to document the rationale for number of monitors and revalidation frequency, as well as other system justifications). (TR52)

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Logistics Service Providers (ISP or 3PIs)

Freight forwarders and brokers that assist in moving the product, but may not physically touch the product. (TR52)

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ISO/IEC

International Organization for Standardization/International Electrotechnical Commision. (TR52)

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First Expiration, First Out (FeFo)

A method of controlling inventory to ensure that the material with the shortest remaining shelf-life is distributed first. (TR52)

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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)

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Change Control

A formal program that describes evaluation and actions to be taken if a change is proposed or completed to facilities, materials, equipment, and/or processes used in the fabrication, packaging, and testing of drugs, or a proposed or completed change that may affect the operation of the quality or support systems. (TR22) (TR39) (TR52) (TR58) (TR64) (TR 70)

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