
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 58: Temp Controlled Distribution (3)
- TR 54: QRM:Manufacturing Operations (2)
- TR 54-2: QRM: Packaging Labeling (2)
- TR 67: Objectionable Microorganisms (2)
- TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry (2)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (2)
- TR 54-4: QRM: Biotech Drug Substance (1)
- TR 55: TBA/TCA Detection Mitigation (1)
- TR 57-2: Analytical Method Development (1)
- TR 68: Drug Shortage Management (1)
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Quality System
Formalized business practices that define management responsibilities for organizational structure, processes, procedures, and resources needed to fulfill product/service requirements, customer satisfaction, and continual improvement. (TR30) (TR44)
The sum of all aspects of a system that implements quality policy and ensures that quality objectives are met. (TR54-5)
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Risk
The combination of the probability of occurrence of harm and the severity of that harm.(TR30) (TR44) (TR54) (TR54-2) (TR54-4) (TR58) (TR67) (TR68) (TR88)
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Risk Assessment
A systematic process of organizing information to support a risk decision to be made within a risk management process. It consists of identification of hazards and the analysis and evaluation of risk associated with exposure to those hazards. (TR30) (TR44) (TR54) (TR58) (TR55) (TR67) (TR57-2) (TR54-5) (TR88)
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Risk Evaluation
The comparison of the estimated risk to given risk criteria using a quantitative or qualitative scale to determine the significance of the risk (TR30) (TR54-2) (TR44) (TR58) (TR54-5)