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.
本年度回望——最少每一年開展一次的一種點評主題活動,即對每個藥品的產(chǎn)品質量標準開展評定以決策是不是必須對藥品技術規(guī)范或生產(chǎn)加工或管理程序進行變更。
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,改正和防范措施,一種系統(tǒng)軟件方式,包含必須糾正的個人行為(改正)、防止再次出現(xiàn)(改正個人行為)、清除潛在性的非一致性商品和其他產(chǎn)品質量問題造成的緣故(防止個人行為)(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)改善——持續(xù)發(fā)展趨勢個人行為,以提升 法律效力為目地,對商品、加工工藝和品質系統(tǒng)軟件開展評定和積極主動變動。
4. Correction– Repair, rework, or adjustment relating to the disposition of an existing discrepancy.
改正——對早已存有的誤差開展挽救、返修或調節(jié)。
5. Corrective Action – Action taken to eliminate the causes of an existing discrepancy or other undesirable situation to prevent recurrence.
糾偏裝置對策——為清除現(xiàn)有誤差或其他不符合規(guī)定的狀況、防止難題的再次出現(xiàn)所采用的行動。
6. Customer– A person or organization (internal or external) that receives a product or service anywhere along the product’s life cycle.
顧客——在商品全部生命期的一切環(huán)節(jié),接到商品或服務項目的本人或機構(內部或外界的)。
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.
誤差——在預期成果范疇外的數(shù)據(jù)信息或結果;沒有做到的規(guī)定;也稱之為非一致性、缺點、偏移、超標準或超過發(fā)展趨勢。
8. Harm– Damage to health, including the damage that can occur from the loss of product quality or availability.
傷害——危害身心健康,包含因產(chǎn)品品質或實效性缺少造成的危害。
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——特點、商品技術規(guī)范、加工工藝主要參數(shù)、紀錄或程序流程上的缺點,使產(chǎn)品品質不能接納、不確定性或不符特殊規(guī)定。
10. Preventive Action– Action taken to eliminate the cause of a potential discrepancy or other undesirable situation to prevent such an occurrence.
防范措施——為清除潛在性誤差或其他不符合規(guī)定的狀況、防止該類難題的再次出現(xiàn)所采用的對策。
11. Product/Service– The intended results of activities or processes; products/services can be tangible or intangible.
商品/服務項目——行動或加工工藝的預估內結果,商品/服務項目能夠是有形化或無形中的。
12. Quality – A measure of a product’s or service’s ability to satisfy the customer’s stated or implied needs.
品質——對商品或服務能力是不是考慮顧客要求或默認設置的要求的一種考量方法。
13. Quality Assurance– Proactive and retrospective activities that provide confidence that requirements are fulfilled.
品質保證——展望或描述性研究的主題活動,以出示符合規(guī)定的自信心。
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.
質量管理——在商品或服務項目加工過程中采用的流程,以保證 商品/服務項目符合規(guī)定并可以反復。
15. Quality Management – Accountability for the successful implementation of the quality system。
質量控制——取得成功落實品質系統(tǒng)軟件的義務。
16. Quality Objectives– Specific measurable activities or processes to meet the intentions and directions as defined in the quality policy.
質量方針——可精確測量的特殊主題活動或全過程,以合乎品質現(xiàn)行政策所定義的目地和方位。
17. Quality Plan – The documented result of quality planning that is disseminated to all relevant levels of the organization.
質量計劃——品質文檔化的方案結果,規(guī)定傳做到組織架構中的全部層級。
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.
品質整體規(guī)劃——一項管理方法主題活動,設置質量方針,并詳盡要求做到該總體目標所必須的實際操作和/或品質系統(tǒng)軟件步驟及其資源。
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.
品質現(xiàn)行政策——機構頂層所公布的與考慮顧客要求有關的目地和方位的申明,它與機構的發(fā)展戰(zhàn)略方位(要勤奮得到 的品質期待)相近。
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.
品質系統(tǒng)軟件——宣布的商業(yè)服務實踐活動,它詳盡要求了管理人員在組織架構、加工工藝、程序流程和資源中的崗位職責,以執(zhí)行商品/服務項目、考慮顧客及其開展持續(xù)改善。
21. Quality Unit– A group organized within an organization to promote quality in general practice.
重量單位——在平時實踐活動中為保證質量,在機構內部創(chuàng)立的一個團隊。
22. Risk– The combination of the probability of occurrence of harm and the severity of that harm.
風險性——傷害產(chǎn)生的概率和比較嚴重度的組成。
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.
風險評價——為了更好地支撐點風險性分辨,在風險性管理流程內所開展的一種針對性機構信息內容的步驟。該方式由傷害的確定、剖析和點評與傷害有關的風險性幾一部分構成。
24. Risk Management – The systematic application of quality management policies, procedures, and practices to the tasks of assessing, controlling, communicating, and reviewing risk.
風險管控——質量控制現(xiàn)行政策、程序流程和實踐活動實際操作的針對性應用,每日任務是對風險性開展評定、操縱、溝通交流和回望。
25. Senior Management– Top management officials in a firm who have the authority and responsibility to mobilize resources.
高層住宅管理方法——公司內的高級管理者,具備鼓勵資源的受權和崗位職責。
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.
相關者——個人或機構,在對品質系統(tǒng)軟件架構內或商業(yè)化的加工工藝改善中的出讓、結果、指標值,有著相對支配權和權益。比如,公司股東等。
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).
確定——確認,根據(jù)出示客觀性直接證據(jù)對要求規(guī)定已獲得考慮的評定。
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).
認證——確認,根據(jù)出示客觀性直接證據(jù)對特殊的預估應用或運用規(guī)定已獲得考慮的評定。
來源于:Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations,藥聞藥事 梳理編寫
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