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1. Annual Review – An evaluation, conducted at least annually, that assesses the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures.
2. CAPA – Corrective and preventive action: A systematic approach that includes actions needed to correct (“correction”), prevent recurrence (“corrective action”), and eliminate the cause of potential nonconforming product and other quality problems (preventive action) (21CFR 820.100).
3. Continual Improvement – Ongoing activities to evaluate and positively change products, processes, and the quality system to increase effectiveness.
4. Correction – Repair, rework, or adjustment relating to the disposition of an existing discrepancy.
5. Corrective Action – Action taken to eliminate the causes of an existing discrepancy or other undesirable situation to prevent recurrence.
6. Customer – A person or organization (internal or external) that receives a product or service anywhere along the product’s life cycle.
7. Discrepancy – Datum or result outside of the expected range; an unfulfilled requirement; may be called non-conformity, defect, deviation, out-of-specification, out-of-limit, out-of-trend.
8. Harm – Damage to health, including the damage that can occur from the loss of product quality or availability.
9. Non-conformity – A deficiency in a characteristic, product specification, process parameter, record, or procedure that renders the quality of a product unacceptable, indeterminate, or not according to specified requirements.
10. Preventive Action – Action taken to eliminate the cause of a potential discrepancy or other undesirable situation to prevent such an occurrence.
11. Product/Service – The intended results of activities or processes; products/services can be tangible or intangible.
12. Quality – A measure of a product’s or service’s ability to satisfy the customer’s stated or implied needs.
13. Quality Assurance – Proactive and retrospective activities that provide confidence that requirements are fulfilled.
14. Quality Control – The steps taken during the generation of a product or service to ensure that it meets requirements and that the product or service is reproducible.
15. Quality Management – Accountability for the successful implementation of the quality system。
16. Quality Objectives – Specific measurable activities or processes to meet the intentions and directions as defined in the quality policy.
17. Quality Plan – The documented result of quality planning that is disseminated to all relevant levels of the organization.
18. Quality Planning – A management activity that sets quality objectives and defines the operational and/or quality system processes and the resources needed to fulfill the objectives.
19. Quality Policy – A statement of intentions and direction issued by the highest level of the organization related to satisfying customer needs. It is similar to a strategic direction that communicates quality expectations that the organization is striving to achieve.
20. Quality System – Formalized business practices that define management responsibilities for organizational structure, processes, procedures, and resources needed to fulfill product/service requirements, customer satisfaction, and continual improvement.
21. Quality Unit – A group organized within an organization to promote quality in general practice.
22. Risk – The combination of the probability of occurrence of harm and the severity of that harm.
23. Risk Assessment – A systematic process for organizing information to support a risk decision that is made within a risk management process. The process consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards.
24. Risk Management – The systematic application of quality management policies, procedures, and practices to the tasks of assessing, controlling, communicating, and reviewing risk.
25. Senior Management – Top management officials in a firm who have the authority and responsibility to mobilize resources.
26. Stakeholder – An individual or organization having an ownership or interest in the delivery, results, and metrics of the quality system framework or business process improvements.
27. Verification – Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled. (Reference: The ASQ Auditing Handbook, 3rd edition, ASQ Quality Audit Division, J.P. Russell, Editor).
28. Validation – Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled. (Reference: The ASQ Auditing Handbook, 3rd edition, ASQ Quality Audit Division, J.P. Russell, Editor).
来自：Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations，药闻药事 整理编辑 |
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