（Cell Bank Maintenance and Record Keeping）
20. 術語彙編（GLOSSARY）
允收標準
對於試驗結果之接受性的數值限量、範圍或 其他適當的量度。
Acceptance Criteria
Numerical limits, ranges, or other suitable measures for acceptance of test results.
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原料藥/藥物
預定用於藥物產品/藥品之製造的任何物質或 物質的混合物，當其使用於藥品的生產時，
成為該藥品之有效成分。該等物質意在對疾 病之診斷、治療、緩解、處理或預防提供藥 理活性或其他直接效應，或意在影響身體之 結構與機能。
Active Pharmaceutical Ingredient (API) (or Drug Substance)
Any substance or mixture of substances
intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active
ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.
原料藥之起始物
使用於原料藥之生產，經化學反應併入該原 料藥結構中，成為其重要化學結構片段之原 料、中間產物或另一原料藥。原料藥之起始 物可以是市售商品，或自一家以上之供應商 依據契約/商業協議採購或在廠內所生產的物 質。通常，原料藥之起始物具有經界定之化 學性質及結構。
API Starting Material
A raw material, intermediate, or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API. An API starting material can be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement, or produced in-house. API starting materials are normally of defined chemical properties and structure.
批
在一個製程中或一系列製程中所生產之特定 量的物質，因此預期在規定的限量內是均質 的。在連續的生產中，一個批次可能是相當 於該生產過程所界定的段落。批量得以一固 定量或以在固定時間間隔內所生產之量來界 定。
Batch (or Lot)
A specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits. In the case of continuous production, a batch may correspond to a defined fraction of the production. The batch size can be defined either by a fixed quantity or by the amount produced in a fixed time interval.
批號
識別一個批次之數字、文字及/或符號的獨特 組合。藉此，可以確定其生產及運銷的歷史。
Batch Number (or Lot Number) A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and from which the production and distribution history can be determined.
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負荷菌
可能存在於原料、原料藥之起始物、中間產 物或原料藥中之微生物的量及類型（例如，
不論其是否為不合宜微生物）。除非其數量 已超過限量，或經界定之不合宜微生物已被 檢出，否則，負荷菌不得認定為污染。
Bioburden
The level and type (e.g. objectionable or not) of micro-organisms that can be present in raw materials, API starting materials, intermediates or APIs. Bioburden should not be considered contamination unless the levels have been exceeded or defined objectionable organisms have been detected.
校正
一特定儀器或裝置，與對照標準品或可追溯 標準品在適當量測範圍內所產生的結果進行 比較，證明其產生之結果在規定限值內。
Calibration
The demonstration that a particular instrument or device produces results within specified limits by comparison with results produced by a reference or traceable standard over an
appropriate range of measurements.
電腦系統
經設計與組裝的一組硬體組件及相關軟體，
以執行一特定功能或一組功能。
Computer System
A group of hardware components and
associated software designed and assembled to perform a specific function or group of
functions.
污染
原料、中間產物或原料藥在生產、抽樣、分 包裝或重分包裝、儲存或運送中，遭受到化 學或微生物學特性之不純物或異物混入。
Contamination
The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a raw material, intermediate, or API during production,
sampling, packaging, or repackaging, storage or transport.
受託製造廠
代表原始製造廠執行一些製造方面的製造 廠。
Contract Manufacturer
A manufacturer performing some aspect of manufacturing on behalf of the original manufacturer.
關鍵性的
敘述必須管制在預定之標準內的製程步驟、
製程條件、試驗要求，或其他相關參數或項 目，以確保原料藥符合其規格。
Critical
Describes a process step, process condition, test requirement, or other relevant parameter or item that must be controlled within predetermined criteria to ensure that the API meets its specification.
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偏差
偏離經核准之指令或既定之標準。
Deviation
Departure from an approved instruction or established standard.
藥物產品/藥品
在最終直接包裝中預定上市之劑型。（參考 ICH Q1A）。
Drug (Medicinal) Product
The dosage form in the final immediate packaging intended for marketing. (Reference Q1A)
藥物/原料藥
參見「原料藥/藥物」。
Drug Substance
See Active Pharmaceutical Ingredient.
末效日期
在原料藥之容器/標籤上所載之日期，指定該 原料藥於所指定期間內，如儲存在所界定的 條件下，可期待維持在既定架儲期規格內，
並且在該日期之後不得使用。
Expiry Date (or Expiration Date)
The date placed on the container/labels of an API designating the time during which the API is expected to remain within established shelf life specifications if stored under defined conditions and after which it should not be used.
不純物
出現於中間產物或原料藥中之任何非所預期 的物質。
Impurity
Any component present in the intermediate or API that is not the desired entity.
不純物描述
對出現於原料藥中之經辨識或未經辨識的不 純物之敘述。
Impurity Profile
A description of the identified and unidentified impurities present in an API.
製程中管制或製程管制
爲監測，或合適時為調整製程及/或確保中間 產物或原料藥符合其規格，而在生產中執行 的檢測。
In-Process Control (or Process Control) Checks performed during production in order to monitor and, if appropriate, to adjust the
process and/or to ensure that the intermediate or API conforms to its specifications.
中間產物
在原料藥之製程步驟中產生的物質。該物質 在變成原料藥前，需要進行進一步之分子改 變或純化。中間產物可以是經分離的或是不 經分離的。（註：本規範只規範在公司界定 為原料藥之開始生產點後所生產的中間產 物。）
Intermediate
A material produced during steps of the processing of an API that undergoes further molecular change or purification before it becomes an API. Intermediates may or may not be isolated. (Note: this Guide only addresses those intermediates produced after the point that the company has defined as the point at which the production of the API begins.)
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製造
原料藥之原物料接收、生產、分裝或包裝、
重分包裝、標示、重標示、品質管制、放行、
儲存，以及運銷等之所有作業及其相關的管 制。
Manufacture
All operations of receipt of materials,
production, packaging, repackaging, labelling, relabelling, quality control, release, storage, and distribution of APIs and related controls.
原物料
用以指稱原料（起始原料、試劑、溶劑）、
製程助劑、中間產物、原料藥，以及分裝或 包裝與標示材料的一般術語。
Material
A general term used to denote raw materials (starting materials, reagents, solvents), process aids, intermediates, APIs, and packaging and labeling materials.
母液
在結晶或分離過程後所留下之殘留液體。母 液可能含有未反應的原料、中間產物、不同 量/濃度的原料藥及/或不純物。這可能用於進 一步處理。
Mother Liquor
The residual liquid which remains after the crystallization or isolation processes. A mother liquor may contain unreacted materials,
intermediates, levels of the API and/or impurities. It may be used for further processing.
包裝材料
預定用在儲存及運送期間保護中間產物或原 料藥之任何物料。
Packaging Material
Any material intended to protect an intermediate or API during storage and transport.
程序
直接或間接與中間產物或原料藥之製造有關 之待執行的作業、待採取之預防及待運用之 措施的文件化說明。
Procedure
A documented description of the operations to be performed, the precautions to be taken, and measures to be applied directly or indirectly related to the manufacture of an intermediate or API.
製程助劑
除溶劑外，其本身不參與化學或生物學反 應，用為中間產物或原料藥之製造的輔助物 質（例如，過濾助劑、活性碳等）。
Process Aids
Materials, excluding solvents, used as an aid in the manufacture of an intermediate or API that do not themselves participate in a chemical or biological reaction (e.g. filter aid, activated carbon, etc).
生產
原料藥之製備所涉及的所有操作，自原物料 接收直到該原料藥之加工及分裝或包裝。
Production
All operations involved in the preparation of an API from receipt of materials through
processing and packaging of the API.
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品質保證
為確保所有原料藥具有其預定用途所需之品 質及其品質系統之維持的目標，所做之整體 有組織的安排。
Quality Assurance (QA)
The sum total of the organised arrangements made with the object of ensuring that all APIs are of the quality required for their intended use and that quality systems are maintained.
品質部門
獨立於生產並履行品質保證與品質管制責任 之組織單元。該單元的型式得為分開之品質 保證部門及品質管制部門或單一個人或一組 人，依組織之大小與結構而定。
Quality Unit(s)
An organizational unit independent of production which fulfills both Quality
Assurance and Quality Control responsibilities.
This can be in the form of separate QA and QC units or a single individual or group, depending upon the size and structure of the organization.
原料
用於指示供中間產物或原料藥生產用之起始 物、試劑及溶劑的一般術語。
Raw Material
A general term used to denote starting
materials, reagents, and solvents intended for use in the production of intermediates or APIs.
一級對照標準品
經由一套廣泛的分析測試已經顯示應為高純 度之真正品質的物質。該標準品可以是：（1）
得自法定認可的來源，或（2）經由獨立合成 所製備，或（3）得自高純度的既有生產物質，
或（4）經由既有生產物質的進一步純化所製 備。
Reference Standard, Primary
A substance that has been shown by an
extensive set of analytical tests to be authentic material that should be of high purity. This standard can be: (1) obtained from an officially recognised source, or (2) prepared by
independent synthesis, or (3) obtained from existing production material of high purity, or (4) prepared by further purification of existing production material.
二級對照標準品
作為例行實驗室分析之對照標準品使用的既 定品質與純度之物質，該品質與純度係與一 級對照標準品的比較所顯示。
Reference Standard, Secondary
A substance of established quality and purity, as shown by comparison to a primary reference standard, used as a reference standard for routine laboratory analysis.
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重處理
將一中間產物或原料藥，包含不符合標準或 規格者在內，導回製程中，並重複結晶步驟 或其他適當的化學或物理操作步驟（例如，
蒸餾、過濾、層析、粉碎），該等步驟為既 定製造過程的一部分。製程中管制試驗已經 顯示該步驟為不完全/尚未完成後，繼續該製 程步驟是被認定為正常製程的一部分而非重 處理。
Reprocessing
Introducing an intermediate or API, including one that does not conform to standards or specifications, back into the process and repeating a crystallization step or other
appropriate chemical or physical manipulation steps (e.g., distillation, filtration,
chromatography, milling) that are part of the established manufacturing process.
Continuation of a process step after an
in-process control test has shown that the step is incomplete is considered to be part of the normal process, and not reprocessing.
再驗日期
當一原料、中間產物或原料藥應當再度檢 驗，以確保其仍然適合使用的日期。
Retest Date
The date when a material should be
re-examined to ensure that it is still suitable for use.
再加工
對不符合標準或規格之中間產物或原料藥，
使其接受已建立之製程的一個或一個以上不 同之步驟製造（例如，使用不同溶劑進行再 結晶），以獲得可接受之品質的中間產物或 原料藥。
Reworking
Subjecting an intermediate or API that does not conform to standards or specifications to one or more processing steps that are different from the established manufacturing process to obtain acceptable quality intermediate or API (e.g., recrystallizing with a different solvent).
簽名（經簽署的）
參見經簽署的定義。
Signature (signed) See definition for signed.
經…簽署（簽名）
執行一特定行動或審查之個人紀錄。該紀錄 得為姓名之首字母、完整手寫簽名、私章或
執行一特定行動或審查之個人紀錄。該紀錄 得為姓名之首字母、完整手寫簽名、私章或