原則（PRINCIPLE）
GMP 指引所涵蓋之任何委外活動應經適 當界定、協議與管制，以避免因誤解而 可能導致不滿意品質的產品或作業。委 託者與受託者間必須有清楚訂定雙方角 色與職責的書面契約。委託者之製藥品 質系統應清楚規定，被授權人認可每批 次產品放行之完整職責的行使方式。
Any activity covered by the GMP Guide that is outsourced should be
appropriately defined, agreed and controlled in order to avoid
misunderstandings which could result in a product or operation of unsatisfactory quality. There must be a written contract between the Contract Giver and the Contract Acceptor which clearly
establishes the roles and responsibilities of each party. The Pharmaceutical Quality System of the Contract Giver must clearly state the way that the Authorised Person certifying each batch of product for release exercises his/her full responsibility.
一般規定（GENERAL）
7.1 應有書面契約涵蓋與相關產品或作業有
關之委外活動，及與該契約之任何有關 的技術安排。
7.1 There should be a written contract covering the outsourced activities, the products or operations to which they are related, and any technical arrangements made in connection with it.
7.2 適用時，對委外活動之所有安排，包括
在技術上或其他安排中所建議之任何變 更，皆應符合現行法規及相關產品之上 市許可。
7.2 All arrangements for the outsourced activities including any proposed changes in technical or other
arrangements should be in accordance with regulations in force, and the
Marketing Authorisation for the product concerned, where applicable.
7.3 上市許可之持有者與製造者不相同時，
應考慮本章節所述之原則做出適當的安 排。
7.3 Where the Marketing Authorisation holder and the manufacturer are not the same, appropriate arrangements should be in place, taking into account the principles described in this chapter.
7.4 委託者的製藥品質系統應包括任何委外 活動的管制與審查。委託者應確認備有 程序，以確保對委外活動的管制負最終 責任。這些程序應包括品質風險管理原 則，並且特別包括：
7.4 The Pharmaceutical Quality System of the Contract Giver should include the control and review of any outsourced activities. The Contract Giver is ultimately responsible to ensure processes are in place to assure the control of outsourced activities. These processes should incorporate quality risk management principles and notably include:
7.4.1 在委外活動進行前，委託者應負 責評估受託者成功履行委外活動 的合法性、合適性及能力。委託 者也負責藉由該契約，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；
7.4.1 Prior to outsourcing activities, the Contract Giver is responsible for assessing the legality,
suitability and the competence of the Contract Acceptor to carry out successfully the outsourced activities. The Contract Giver is also responsible for ensuring by means of the contract that the principles and guidelines of GMP as interpreted in this Guide are followed;
7.4.2 委託者應提供受託者所有必需的 資訊及知識，以使其依產品相關 的現行法規及上市許可，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；
7.4.2 The Contract Giver should provide the Contract Acceptor with all the information and knowledge necessary to carry out the contracted operations correctly in accordance with regulations in force, and the Marketing Authorisation for the product concerned. 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/her premises, equipment, personnel, other materials or other products;
7.4.3 委託者應監督與檢討受託者的表 現，以及識別與實施任何需要的 改進。
7.4.3 The Contract Giver should monitor and review the performance of the Contract Acceptor and the identification and implementation of any needed improvement.
7.5 委託者應負責審查及評估與委外活動相
關之紀錄與結果。無論是由委託者親自 或基於受託者之被授權人的確認，委託 者應確保受託者所交付之所有產品及原 物料皆依 GMP 及上市許可進行處理。
7.5 The Contract Giver should be
responsible for reviewing and assessing the records and the results related to the outsourced activities. He/she should also ensure, either by himself/herself, or based on the confirmation of the
Contract Acceptor’s Authorised Person, that all products and materials delivered to him/her by the Contract Acceptor have been processed in accordance with GMP and the Marketing Authorisation.
受託者（THE CONTRACT ACCEPTOR）
7.6 受託者應能令人滿意地執行委託者所託
付的工作，例如有適當的廠房設施、設 備、知識、經驗及能勝任的人員。
7.6 The Contract Acceptor must be able to carry out satisfactorily the work ordered by the Contract Giver such as having adequate premises, equipment,
knowledge, experience, and competent personnel.
7.7 受託者應確認所被交付的所有產品、原
物料與知識皆符合其預定之目的。
7.7 The Contract Acceptor should ensure that all products, materials and knowledge delivered to him/her are suitable for their intended purpose.
7.8 受託者未經委託者之事先評估及同意，
不得將契約所委託的任何工作轉委託給 第三方。受託者與任何第三方間所做的 安排，應確保包含來自第三方之合適性 評估的資訊及知識，以原委託者與受託 者間約定的相同方式提供之。
7.8 The Contract Acceptor should not subcontract to a third party any of the work entrusted to him/her 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
information and knowledge, including those from assessments of the suitability of the third party, are made available in the same way as between the original Contract Giver and Contract Acceptor.
7.9 受託者不應做合約條款以外未經授權之
變更，因其可能對委託者之委外活動造 成品質不良的影響。
7.9 The Contract Acceptor should not make unauthorised changes, outside the terms of the Contract, which may adversely affect the quality of the outsourced activities for the Contract Giver.
7.10 受託者應瞭解委外活動（包含檢驗等）
可能會受到主管機關之檢查。
7.10 The Contract Acceptor should
understand that outsourced activities, including contract analysis, may be subject to inspection by the competent authorities.
契約（THE CONTRACT）
7.11 委託者與受託者間應簽訂契約。該契約
7.11 A contract should be drawn up between the Contract Giver and the Contract Acceptor which specifies their respective responsibilities and
communication processes relating to the outsourced activities. Technical aspects of the contract should be drawn up by competent persons suitably
knowledgeable in related outsourced activities and Good Manufacturing Practice. All arrangements for outsourced activities must be in
accordance with regulations in force and the Marketing Authorisation for the product concerned and agreed by both parties.
7.12 The contract should describe clearly which party to the contract has
responsibility for conducting each step of the outsourced activity, e.g.
knowledge management, technology transfer, supply chain, subcontracting, quality and purchasing of materials, testing and releasing materials, undertaking production and quality controls (including in-process controls, sampling and analysis).
7.13 所有委外活動之相關紀錄應由委託者保
7.13 All records related to the outsourced activities, e.g. 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 or to investigating in the case of a suspected falsified product must be accessible and specified in the relevant procedures of the
7.14 契約應明訂容許委託者稽查受託者所執 行或雙方同意之轉委託商所執行的委外 活動。
7.14 The contract should permit the Contract Giver to audit outsourced activities, performed by the Contract Acceptor or their mutually agreed subcontractors.