
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 54: QRM:Manufacturing Operations (1)
- TR 54-2: QRM: Packaging Labeling (1)
- TR 54-3: QRM: Drug Products (1)
- TR 54-4: QRM: Biotech Drug Substance (1)
- TR 72: Passive Thermal Protection Systems: Qualification/Operations (1)
- TR 74: Reprocessing of Biopharmaceuticals (1)
- TR 44: QRM: Aseptic Processes (1)
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Failure Mode and Effects Analysis (FMEA)
A method of assessing and evaluating risk. (TR44)
A systematic method for identifying, analyzing, prioritizing and documenting potential failure modes, their effects on system, product and process performance, and the possible causes of failure in order to prevent defects from occurring. (TR54) (TR54-2) (TR54-3) (TR54-4) (TR74) (TR54-5)
A tool for analyzing processes or systems to evaluate all operating steps in order to identify and assess the risk associated with any potential failures. (TR65)
An analytical technique that results in a rankordered list of concerns to take action on. (TR72)
Source:
Process Flow Diagram (PFD)
A document, typically prepared by R&D, that describes the intended manufacturing process. The PFD includes all relevant information for the operation of the manufacturing process, organized by unit operation. The PFD serves as the source document for the initial development of the master production records and is locked down once development has determined that the process can be controlled. (TR65)