Quality Assurance
Quality by Design
Quality Control
Quality Improvement Plan
Quality Management System
Quality Risk Management Data Sheet
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. For qualification of excipient, refer to IPEC Qualification of Excipient Guide. [21] [43]
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 that all excipients for pharmaceutical use are of the quality required for their intended use and that quality systems are maintained.[21]
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. [9]
Checking or testing that specifications are met.[21]
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]
A management system that directs and controls how the organization implements quality policies and achieves quality objectives.NOTE — Requirements for quality management systems can be found in ISO 9001 and ICH Q10. [1]
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). [2] [9]
An organizational unit independent of production which fulfils 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.[21]
The status of materials isolated physically or by other effective means pending a decision on their subsequent approval or rejection.[21]
