原則（PRINCIPLE）
委受託製造與檢驗應正確地予以界定、
協議及管制，以避免因誤解而可能導致 不滿意品質的產品或作業。委託者與受 託者間應有清楚訂定雙方職責的書面契 約。該契約應清楚約定，負責放行每批 供銷售之產品的被授權人員執行其完整 職責的方式。
Contract manufacture and analysis must be correctly defined, agreed and controlled in order to avoid misunderstandings which could result in a product or work of unsatisfactory quality. There must be a written contract between the Contract Giver and the Contract Acceptor which clearly establishes the duties of each party. The contract must clearly state the way in which the authorised person releasing each batch of product for sale exercises his full responsibility.
註：本章規定藥廠對於授予銷售與製造 許可之主管機關應負的責任。本章 無意以任何方式影響委託者與受 託者對於消費者之個別義務。
Note: This Chapter deals with the responsibilities of manufacturers towards the Component Authorities of the Participating authorities with respect to the granting of marketing and manufacturing authorisations. It is not intended in any way to affect the respective liability of contract acceptors and contract givers to consumers.
一般規定（GENERAL）
7.1 該委託契約，應有涵蓋製造及/或委/受 託檢驗之書面契約及其有關的技術安 排。
7.1 There should be a written contract covering the manufacture and/or analysis arranged under contract and any technical
arrangements made in connection with it.
7.2 為委受託製造與檢驗之所有安排，包括 技 術 或 其 他 安 排 中 所 建 議 之 任 何 改 變，均應符合相關產品之上市許可。
7.2 All arrangements for contract manufacture and analysis including any proposed changes in technical or other arrangements should be in accordance with the
marketing authorisation for the product concerned.
委託者（THE CONTRACT GIVER）
7.3 委託者應負責評估受託者成功履行要 求之工作的能力，並負責藉由該契約，
確保本指引所闡釋之優良製造規範的 原則與指引受到遵循。
7.3 The Contract Giver is responsible for assessing the competence of the Contract Acceptor to carry out successfully the work required and for ensuring by means of the contract that the principles and Guidelines of GMP as interpreted in this Guide are followed.
7.4 委 託 者 應 提 供 受 託 者 所 有 必 需 的 資 訊，以使其依上市許可及任何其他法律 要求，正確地履行約定的作業。委託者 應確保受託者完全認知與本產品或工 作有關之任何可能會對其廠房設施、設 備、人員、其他原物料或其他產品造成 危害的問題。
7.4 The Contract Giver should provide the Contract Acceptor with all the information necessary to carry out the contracted operations correctly in accordance with the marketing authorisation and any other legal requirements. The Contract Giver should ensure that the Contract Acceptor is fully aware of any problems associated with the product or the work which might pose a hazard to his premises, equipment, personnel, other materials or other products.
7.5 委託者應確保受託者所交付之所有處 理過的產品及原物料均符合其規格，或 這些產品係經由被授權人員放行。
7.5 The Contract Giver should ensure that all processed products and materials delivered to him by the Contract Acceptor comply with their specifications or that the products have been released by an authorised person.
受託者（THE CONTRACT ACCEPTOR）
7.6 受託者應有適當的廠房設施與設備、知 識與經驗及能勝任的人員，滿意地執行 委託者所託付的工作。接受委託製造僅 得由取得製造許可者為之。
7.6 The Contract Acceptor must have adequate premises and equipment, knowledge and experience, and competent personnel to carry out satisfactorily the work ordered by the Contract Giver. Contract manufacture may be undertaken only by a manufacturer who is the holder of a manufacturing authorisation.
7.7 受託者應確認所交付的所有產品或原 物料皆符合其預定之目的。
7.7 The Contract Acceptor should ensure that all products or materials delivered to him are suitable for their intended purpose.
7.8 受 託 者 未 經 委 託 者 之 事 先 評 估 及 同 7.8 The Contract Acceptor should not pass to a
意，不得將契約所委託的任何工作轉託 給第三方。受託者與任何第三方間所做 的任何安排，應確保其製造及檢驗資訊 以原委託者與受託者間約定的相同方 式提供之。
third party any of the work entrusted to him under the contract without the Contract Giver's prior evaluation and approval of the arrangements.
Arrangements made between the Contract Acceptor and any third party should ensure that the manufacturing and analytical information is made available in the same way as between the original Contract Giver and Contract Acceptor.
7.9 受託者應避免對委託者委託製造及/或 檢驗之產品品質可能會造成不良影響 的任何活動。
7.9 The Contract Acceptor should refrain from any activity which may adversely affect the quality of the product manufactured and/or analysed for the Contract Giver.
合約（THE CONTRACT）
7.10 委託者與受託者間應簽訂契約。該契約 明定雙方關於產品製造與管制的個別 責任。契約中的技術層面應由具有製藥 技術、檢驗及優良製造規範之適當知識 的勝任人員擬定。製造及檢驗的所有安 排均應依上市許可的規定，並為雙方所 同意。
7.10 A contract should be drawn up between the Contract Giver and the Contract Acceptor which specifies their respective
responsibilities relating to the manufacture and control of the product. Technical aspects of the contract should be drawn up by competent persons suitably
knowledgeable in pharmaceutical technology, analysis and Good
Manufacturing Practice. All arrangements for manufacture and analysis must be in accordance with the marketing
authorisation and agreed by both parties 7.11 契約應明定被授權人員放行供銷售之
批次的方式，以確保每一批次皆已符合 上市許可的要求而製造與檢查/核對。
7.11 The contract should specify the way in which the authorised person releasing the batch for sale ensures that each batch has been manufactured and checked for compliance with the requirements of Marketing Authorisation.
7.12 契約中應清楚載明何方負責採購、測試 及放行原物料、承擔生產及品質管制，
含製程中管制，以及何方負責抽樣及檢 驗。委託檢驗契約中應載明受託者是否 應於製造者之廠房中抽樣。
7.12 The contract should describe clearly who is responsible for purchasing materials, testing and releasing materials, undertaking production and quality controls, including in-process controls, and who has
responsibility for sampling and analysis. In
the case of contract analysis, the contract should state whether or not the Contract Acceptor should take samples at the premises of the manufacturer.
7.13 製造、檢驗及運銷之紀錄及對照樣品應 由委託者保存，或可為委託者取得。當 有申訴或懷疑有瑕疵時，應能取得與產 品品質評估有關的任何紀錄。這應明定 於委託者之不良品/回收程序中。
7.13 Manufacturing, analytical and distribution records, and reference samples should be kept by, or be available to, the Contract Giver. Any records relevant to assessing the quality of a product in the event of complaints or a suspected defect must be accessible and specified in the defect/recall procedures of the Contract Giver.
7.14 契約應明定容許委託者訪視受託者的 廠房設施及設備。
7.14 The contract should permit the Contract Giver to visit the facilities of the Contract Acceptor.
7.15 委/受託檢驗時，受託者應了解其應受主 管機關的查核。
7.15 In case of contract analysis, the Contract Acceptor should understand that he is subject to inspection by the competent Authorities.