Quality Assurance
Quality by Design
Quality Control
Quality Improvement Plan
Quality Management System
Quality Risk Management Data Sheet
Quality Target Product Profile
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.
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]
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. [QbD Sample] [2] [9]
