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(jìn)行一次的一種評價活動，即對每種藥物的質(zhì)量標(biāo)準(zhǔn)進(jìn)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(jìn)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(jìn)——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(jìn)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(jìn)行補(bǔ)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(dá)到的要求；也稱作非一致性、缺陷、偏離、超標(biāo)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(rèn)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(fù)。
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(zé)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(biāo)——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(dá)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(biāo)，并詳細(xì)規(guī)定達(dá)到該目標(biāo)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(xì)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(zé)，以履行產(chǎn)品/服務(wù)、滿足消費者以及進(jìn)行持續(xù)改進(jìn)。
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(tuán)體。
22. Risk – The combination of the probability of occurrence of harm and the severity of that harm.
風(fēng)險——危害發(fā)生的可能性和嚴(yán)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(fēng)險評估——為了支撐風(fēng)險判斷，在風(fēng)險管理程序內(nèi)所進(jìn)行的一種系統(tǒng)性組織信息的流程。該方法由危害的確認(rèn)、分析和評價與危害相關(guān)的風(fēng)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(fēng)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(fēng)險進(jìn)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(zé)。
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(jìn)中的轉(zhuǎn)讓、結(jié)果、指標(biāo)，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(rèn)——證實，通過提供客觀證據(jù)對規(guī)定要求已得到滿足的認(rèn)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(rèn)定。
來自：Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations，藥聞藥事 整理編輯
