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.

• 年度回顧——至少每年進行一次的一種評價活動，即對每種藥物的質(zhì)量標準進行評估以決定是否需要對藥物規(guī)程或生產(chǎn)制造或控制程序進行變更。

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).

• CAPA——Corrective and prevention action，糾正和預(yù)防措施，一種系統(tǒng)方法，包括需要改正的行為（糾正）、預(yù)防再次發(fā)生（糾正行為）、消除潛在的非一致性產(chǎn)品和其它質(zhì)量問題產(chǎn)生的原因（預(yù)防行為）（21 CFR 800.100）。

3. Continual Improvement – Ongoing activities to evaluate and positively change products, processes, and the quality system to increase effectiveness. 

• 持續(xù)改進——不斷發(fā)展行為，以提高效力為目的，對產(chǎn)品、工藝和質(zhì)量系統(tǒng)進行評估和積極變更。

4. Correction – Repair, rework, or adjustment relating to the disposition of an existing discrepancy.

• 糾正——對已經(jīng)存在的偏差進行補救、返工或調(diào)整。 

5. Corrective Action – Action taken to eliminate the causes of an existing discrepancy or other undesirable situation to prevent recurrence.

• 糾偏措施——為消除現(xiàn)存偏差或其它不合乎要求的情況、預(yù)防問題的再次發(fā)生所采取的行動。 

6. Customer – A person or organization (internal or external) that receives a product or service anywhere along the product’s life cycle.

• 消費者——在產(chǎn)品整個生命周期的任何階段，收到產(chǎn)品或服務(wù)的個人或組織（內(nèi)部或外部的）。 

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.

• 偏差——在預(yù)期結(jié)果范圍外的數(shù)據(jù)或結(jié)果；沒有達到的要求；也稱作非一致性、缺陷、偏離、超標或超出趨勢。

8. Harm – Damage to health, including the damage that can occur from the loss of product quality or availability.

• 危害——損害健康，包括因產(chǎn)品質(zhì)量或有效性缺失引起的損害。 

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.

• 非一致性——特性、產(chǎn)品規(guī)程、工藝參數(shù)、記錄或程序上的缺陷，使產(chǎn)品質(zhì)量不可接受、不確定或不符合特定要求。 

10. Preventive Action – Action taken to eliminate the cause of a potential discrepancy or other undesirable situation to prevent such an occurrence.

• 預(yù)防措施——為消除潛在偏差或其它不合乎要求的情況、預(yù)防此類問題的再次發(fā)生所采取的措施。 

11. Product/Service – The intended results of activities or processes; products/services can be tangible or intangible.

• 產(chǎn)品/服務(wù)——行動或工藝的預(yù)期內(nèi)結(jié)果，產(chǎn)品/服務(wù)可以是有形或無形的。 

12. Quality – A measure of a product’s or service’s ability to satisfy the customer’s stated or implied needs.

• 質(zhì)量——對產(chǎn)品或服務(wù)能力是否滿足消費者規(guī)定或默認的需求的一種衡量方式。 

13. Quality Assurance – Proactive and retrospective activities that provide confidence that requirements are fulfilled.

• 質(zhì)量保證——前瞻或回顧性的活動，以提供符合要求的信心。

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.

• 質(zhì)量控制——在產(chǎn)品或服務(wù)生產(chǎn)過程中采取的步驟，以確保產(chǎn)品/服務(wù)符合要求并能夠重復。 

15. Quality Management – Accountability for the successful implementation of the quality system。

• 質(zhì)量管理——成功貫徹質(zhì)量系統(tǒng)的責任。

16. Quality Objectives – Specific measurable activities or processes to meet the intentions and directions as defined in the quality policy.

• 質(zhì)量目標——可測量的特定活動或過程，以符合質(zhì)量政策所界定的目的和方向。 

17. Quality Plan – The documented result of quality planning that is disseminated to all relevant levels of the organization.

• 質(zhì)量計劃——質(zhì)量文件化的計劃結(jié)果，要求傳達到組織結(jié)構(gòu)中的所有層次。 

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.

• 質(zhì)量規(guī)劃——一項管理活動，設(shè)定質(zhì)量目標，并詳細規(guī)定達到該目標所需要的操作和/或質(zhì)量系統(tǒng)流程以及資源。

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.

• 質(zhì)量政策——組織最高層所發(fā)布的與滿足消費者需求相關(guān)的目的和方向的聲明，它與組織的戰(zhàn)略方向（要努力獲得的質(zhì)量期望）類似。

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.

• 質(zhì)量系統(tǒng)——正式的商業(yè)實踐，它詳細規(guī)定了管理者在組織結(jié)構(gòu)、工藝、程序和資源中的職責，以履行產(chǎn)品/服務(wù)、滿足消費者以及進行持續(xù)改進。 

21. Quality Unit – A group organized within an organization to promote quality in general practice.

• 質(zhì)量單位——在日常實踐中為提高質(zhì)量，在組織內(nèi)部成立的一個團體。

22. Risk – The combination of the probability of occurrence of harm and the severity of that harm.

• 風險——危害發(fā)生的可能性和嚴重度的組合。 

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.

• 風險評估——為了支撐風險判斷，在風險管理程序內(nèi)所進行的一種系統(tǒng)性組織信息的流程。該方法由危害的確認、分析和評價與危害相關(guān)的風險幾部分組成。

24. Risk Management – The systematic application of quality management policies, procedures, and practices to the tasks of assessing, controlling, communicating, and reviewing risk.

• 風險管理——質(zhì)量管理政策、程序和實踐操作的系統(tǒng)性運用，任務(wù)是對風險進行評估、控制、溝通和回顧。 

25. Senior Management – Top management officials in a firm who have the authority and responsibility to mobilize resources.

• 高層管理——企業(yè)內(nèi)的高級管理人員，具有動員資源的授權(quán)和職責。

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.

• 利益相關(guān)者——個體或組織，在對質(zhì)量系統(tǒng)框架內(nèi)或商業(yè)化工藝改進中的轉(zhuǎn)讓、結(jié)果、指標，擁有相應(yīng)權(quán)利和利益。例如，股東等。

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). 

• 確認——證實，通過提供客觀證據(jù)對規(guī)定要求已得到滿足的認定。

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).

• 驗證——證實，通過提供客觀證據(jù)對特定的預(yù)期使用或應(yīng)用要求已得到滿足的認定。

來自：Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations，藥聞藥事 整理編輯