Quarantine
(Manufacturing) It is the status of starting or packaging materials, intermediates, or bulk or finished products isolated physically or by other effective means while a decision is awaited on their release, rejection or reprocessing.
Quantitation Limit
The lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy.
Quantitative Interaction
Situations where the direction of the difference in treatment effects varies at least at one level of the factor.
Quantitative Synthesis
A method such as meta-analysis, decision analysis, cost-effectiveness analysis that uses statistical techniques to organize and combine the results of primary studies to summarize them.
Quarantine
(Manufacturing) It is the status of starting or packaging materials, intermediates, or bulk or finished products isolated physically or by other effective means while a decision is awaited on their release, rejection or reprocessing.
Quasi-Randomization / Quasi-Random Allocation
The allocation of clinical trial participants to an intervention or control group using methods that are not truly random but still intended to produce similar groups. eg. assignment based on patient number.
Qualification
Action of proving that any premises, systems and items of equipment work correctly and actually lead to the expected results. The meaning of the world “validation” is sometimes extended to incorporate the concept of qualification.
Quaternary structure
The structure of proteins which are themselves composed of two or more smaller protein chains (also referred to as subunits). Protein quaternary structure describes the number and arrangement of multiple folded protein subunits in a multi-subunit complex.
Qualitative interaction
Situations where the size of the difference in treatment effects varies according to the level of the factor.
Query
A request for clarification regarding the clarity of data collected during the clinical trial process, asking the investigator to address errors or inconsistencies identified by the sponsor or sponsor-related personnel during their review of the data.
Quality Assurance
The sum total of the organized arrangements made with the object of ensuring that all APIs are of the quality required for their intended use and that quality systems are maintained.
Quality by Design (QbD)
A strategic approach employed in various industries, including pharmaceuticals, manufacturing, and product development, to ensure the consistent delivery of high-quality products.
Quality Control
Part of Good Manufacturing Practice deals specifically with sampling, testing, and documentation. GMP quality control is used to ensure that all preliminary testing is carried out and that the quality of the final product has been deemed to meet all standards.
Quality Management Systems (QMS)
A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.
Quality Manual
A document that defines the quality management system of an organisation and demonstrates how the quality management system should function.
Quality Planning
A document that together specify quality standards, practices, resources, specifications, and the sequence of activities relevant to a particular product, service, project, or contract.
Quality Policy
A brief statement that aligns with an organization’s purpose, mission, and strategic direction, providing a framework for quality objectives and includes a commitment to meet applicable requirements.
Quality Risk Management (QRM)
A systematic process for assessing, controlling, communicating, and reviewing risks to the quality of medicinal products throughout the product life cycle. QRM can be applied to all product life cycle stages, from product development to manufacturing, distribution, and post-market surveillance.
Quality Unit
An organizational unit independent of production which fulfills both quality assurance (QA) and quality control (QC) responsibilities. This can be in the form of separate QA and QC units or a single individual or group, depending upon the size and structure of the organization.