14.40 若反應物、中間產物或原料藥有核准的 回收程序，且回收之物質適合其預定用 途之規格時，則回收（例如，從母液或 濾液）認定為可以接受。
14.40 Recovery (e.g., from mother liquor or filtrates) of reactants, intermediates, or the API is considered acceptable, provided that approved procedures exist for the recovery and the recovered materials meet specifications suitable for their intended use.
14.41 若溶劑回收的程序經管制及監測，以確 保該溶劑在重用或與其他經核准之物 質混合前符合適當標準時，則該溶劑得 在相同或不同之製程中回收及重用。
14.41 Solvents can be recovered and reused in the same processes or in different processes, provided that the recovery procedures are controlled and monitored to ensure that solvents meet appropriate standards before reuse or co-mingling with other approved materials.
14.42 新的及回收的溶劑，以及新的及回收的 試劑，若經充分測試已顯示對可能被使 用之所有製造過程的適用性時，則新的 及回收的溶劑/試劑得以合併。
14.42 Fresh and recovered solvents and reagents can be combined if adequate testing has shown their suitability for all manufacturing processes in which they may be used.
14.43 回收的溶劑、母液，以及其他回收物質 的使用，應予適當地文件化。
14.43 The use of recovered solvents, mother liquors, and other recovered materials should be adequately documented.
14.5 退回品（Returns）
14.50 退回的中間產物或原料藥應予以識別 並加隔離。
14.50 Returned intermediates or APIs should be identified as such and quarantined.
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14.51 若退回的中間產物或原料藥在其退回 以前之儲存或運送的條件，或其容器的 狀況，使其品質有所疑慮時，則退回的 中間產物或原料藥得視情況予以重處 理、再加工或銷毀。
14.51 If the conditions under which returned intermediates or APIs have been stored or shipped before or during their return or the condition of their containers casts doubt on their quality, the returned intermediates or APIs should be
reprocessed, reworked, or destroyed, as appropriate.
14.52 退回的中間產物或原料藥之紀錄應予 保存。就每ㄧ退回物件之文件應包括：
14.52 Records of returned intermediates or APIs should be maintained. For each return, documentation should include:
收貨人之姓名及地址 Name and address of the consignee
退回之中間產物或原料藥的批號 及數量
Intermediate or API, batch number, and quantity returned
退回的理由 Reason for return
退回之中間產物或原料藥的使用 或處置
Use or disposal of the returned intermediate or API
15. 申訴與回收（COMPLAINTS AND RECALLS）
15.10 無論是以口頭或書面收到之所有與品 質有關的申訴，均應依照書面程序加以 記錄及調查。
15.10 All quality related complaints, whether received orally or in writing, should be recorded and investigated according to a written procedure.
15.11 申訴紀錄應包括： 15.11 Complaint records should include:
申訴者之姓名及地址； Name and address of complainant;
提出該申訴的人之姓名（及合適 時，其頭銜）及電話號碼；
Name (and, where appropriate, title) and phone number of person
submitting the complaint;
申訴之本質（包含原料藥的名稱及 批號）；
Complaint nature (including name and batch number of the API);
收到申訴的日期； Date complaint is received;
初始採取的行動（包含採取該行動 之日期及人員的身分）；
Action initially taken (including dates and identity of person taking the action);
任何所採取之追蹤行動； Any follow-up action taken;
提供給原申訴人的回應（包含送出 回應的日期）；
Response provided to the originator of complaint (including date
response sent); and
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對中間產物或原料藥批次的最終 決定。
Final decision on intermediate or API batch or lot.
15.12 為評估趨勢、產品相關的申訴頻度及嚴 重性，以便採取追加的與立即的（合適 時）改正措施，申訴紀錄應予保存。
15.12 Records of complaints should be retained in order to evaluate trends, product-related frequencies, and severity with a view to taking additional, and if appropriate, immediate corrective action.
15.13 應有書面程序，界定中間產物或原料藥 應考慮回收的情況。
15.13 There should be a written procedure that defines the circumstances under which a recall of an intermediate or API should be considered.
15.14 回收程序應指定參與評估該資訊的人 員、應如何啟動回收、該回收應被通知 的對象，以及應如何處理回收品。
15.14 The recall procedure should designate who should be involved in evaluating the information, how a recall should be initiated, who should be informed about the recall, and how the recalled material should be treated.
15.15 有嚴重或可能危及生命之情況時，應通 知當地、國家及/或國際主管機關並徵 詢其意見。
15.15 In the event of a serious or potentially life-threatening situation, local, national, and/or international authorities should be informed and their advice sought.
16. 委受託製造廠（含實驗室）【CONTRACT MANUFACTURERS (INCLUDING LABORATORIES)】
16.10 所有受託製造廠（含實驗室）應遵守本 規範中所界定的 GMP。對於防止交叉 污染及保持可追溯性應予特別考慮。
16.10 All contract manufacturers (including laboratories) should comply with the GMP defined in this Guide. Special consideration should be given to the prevention of cross-contamination and to maintaining traceability.
16.11 委託者應評估受託製造廠（含實驗 室），以確保在受託場所執行之特定作 業符合 GMP。
16.11 Contract manufacturers (including laboratories) should be evaluated by the contract giver to ensure GMP
compliance of the specific operations occurring at the contract sites.
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16.12 委託者與其受託者間應有經核准的書 面合約或正式的協議書，詳細界定 GMP 責任，包含每一方的品質措施在 內。
16.12 There should be a written and approved contract or formal agreement between the contract giver and the contract acceptor that defines in detail the GMP responsibilities, including the quality measures, of each party.
16.13 該合約書應允許委託者稽查其受託者 之廠房/設施的 GMP 符合性。
16.13 The contract should permit the contract giver to audit the contract acceptor's facilities for compliance with GMP.
16.14 在容許轉委託時，非經委託者就該轉委 託之安排的事先評估及核准，受託者不 得將任何依照合約書所受託的工作轉 委託給第三方。
16.14 Where subcontracting is allowed, the contract acceptor should not pass to a third party any of the work entrusted to him under the contract without the contract giver's prior evaluation and approval of the arrangements.
16.15 製造及實驗紀錄應保存在執行該作業 活動之場所且易於取得。
16.15 Manufacturing and laboratory records should be kept at the site where the activity occurs and be readily available.
16.16 除非通知委託者並經其核准，不得就製 程、設備、試驗方法、規格或其他合約 之要求事項作出變更。
16.16 Changes in the process, equipment, test methods, specifications, or other contractual requirements should not be made unless the contract giver is informed and approves the changes.
17. 代理商、貿易商、經銷商、重分包裝廠及重標示廠（AGENTS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELLERS）
17.1 適用性（Applicability）
17.10 本章適用於原製造廠以外，從事原料藥 或中間產物之貿易及/或持有、重分包 裝、重標示、處理、運銷或儲存的任何 一方。
17.10 This section applies to any party other than the original manufacturer who may trade and/or take possession, repack, relabel, manipulate, distribute, or store an API or intermediate.
17.11 所有代理商、貿易商、經銷商、重分包 裝廠及重標示廠皆應符合本規範所界 定之 GMP。
17.11 All agents, traders, distributors,
repackers, and relabellers should comply with GMP as defined in this Guide.
17.2 運銷之原料藥及中間產物的可追溯性