Glossary Terms (Simple List)
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Qualification Documentation
Documentation to prove that an installation/ equipment/process is designed and/or tested according to predefined specifications. Documentation may include Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). (TR58)
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Qualification or Validation Set
A set is used for the qualification of manual, semiautomated, and validation of automated inspection to determine the acceptability of performance. (TR79)
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Qualified Assay
An assay that is not fully validated but is documented to be suitable for its intended use, including sample collection and handling procedures. Such an assay should be demonstrated to be accurate, precise, linear within the range of use, and show no interference from process stream components (i.e., spike recovery). (TR42) (TR60-3)
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Qualified Person (QP)
An individual as defined in the European Union pharmaceutical regulation as described in Directive 2001/83/EC that has the legal responsibility for batch release of medicinal products.
Note: See also EU GMP Annex 16, Certification by a Qualified Person and Batch Release. (TR56) -
Qualified Shipping Packaging
Packaging that has been subjected to document testing that demonstrates with a high degree of assurance that a specific process will meet its predetermined acceptance criteria. Due to the “real world” nature of transportation, a qualified process may change over time, requiring appropriate monitoring. (TR46)
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Quality
The degree to which a set of inherent properties of a product, system or process fulfills requirements. The suitability of either a drug substance or drug product for its intended use. This term includes such attributes as the identity, strength and purity. (TR44) (TR57)
The suitability of either a drug substance or drug product for its intended use. This term includes such attributes as the identity, strength and purity. (TR60) (TR60-2)
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Quality Assurance (QA)
The sum total of the organized arrangements made with the object of ensuring that all materials are of the quality required for their intended use and that quality system is maintained. (TR56)
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Quality Attribute
A molecular or product characteristic that is selected for its ability to help indicate the quality of the product, such as identity, purity, potency stability and safety. (TR57) (TR57-2)
A molecular or product characteristic that is selected for its ability to indicate the quality of the product. Collectively, the quality attributes define identity, purity, potency, and stability of the product, and safety with respect to adventitious agents. Specifications measure a selected subset of the quality attributes. (TR60-2) -
Quality by Design (QbD)
QbD is utilization of a more systematic and scientific approach to development for enhanced process understanding, so that better controls may be implemented. (TR54-4)
A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. (TR60)(TR80)
Framework enabling the attainment of the desired state; systematic approach to development that begins with predefined objectives and that emphasizes product and process understanding and process control based on sound science and quality risk management. (TR57-2)
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Quality Management (QM)
System for Transport Service Providers:A QM system that may cover topics such as, but not limited to:(TR39) GMP/GDP relevant processes identified and described in standard procedures, a procedure to identify the main functions of individuals, roles and responsibilities, and contact information of relevant individuals in the case of a deviation, an adequate change control system and an adequate deviation management system, including procedures for corrective actions