Quality by Design
Quality Management System
Quality Target Product Profile
Action of proving and documenting that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results. Qualification is part of validation, but the individual qualification steps alone do not constitute process validation. 
A limit above (>) which an impurity should be qualified. 
The suitability of an excipient for its intended use as indicated by relevant physical, chemical, and microbiological properties and as assured by compliance with this standard.
A formal agreement between the excipient manufacturer and their pharmaceutical customer that stipulates the responsibilities of each party in meeting the regulatory requirements for sale and use of the excipient in a dosage form. 
The sum total of the organized arrangements made with the object of ensuring all excipients are of the quality required for their intended use and that quality systems are maintained. [1, 2, 3]
The disciplines having the responsibility and authority to assure the excipient conforms to its specifications and is produced under appropriate GMPs. 
A philosophy built on the premise that "Quality cannot be tested into a product or operation, it must be built in during the whole development and manufacturing cycle".
Checking or testing that specifications are met. [1, 2, 3]
Describes a material, process step or process condition, test requirement or any other relevant parameter that directly influences the quality attributes of the excipient and which must be controlled within predetermined criteria. [1, 3]
Any document, such as a procedure, record, policy, or form that is used in support of the IPEA Quality Management System. (SOP 0)
A management system that directs and controls how the organization implements quality policies and achieves quality objectives.
Document specifying the quality management system of an organisation. (ISO 9000:2005) 
A means to translate the quality policy and strategies into measurable activities. (ICH Q10) 
Part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfil the quality objectives. (ISO 9000:2005) 
Overall intentions and direction of an organisation related to quality as formally expressed by senior management.(ISO 9000:2005) 
A document that demonstrates conformance to a procedure or work instruction that is part of the quality system. (Quality Manual)
A systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle. 
See "Quality Management System"
A prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy of the drug product (ICH definition)
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. 
Describes a material, process step or process condition, test requirement or any other relevant parameter that directly influences the quality attributes of the excipient and which must be controlled within predetermined criteria.
The quantitation limit of an individual analytical procedure is the lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy. The quantitation limit is a parameter of quantitative assays for low levels of compounds in sample matrices, and is used particularly for the determination of impurities and/or degradation products. 
The status of materials isolated physically or by other effective means pending a decision on their subsequent approval or rejection. [1, 2, 3, 18]